Pharmacology and the Nursing Process (Linda Lane Lilley, Shelly Rainforth Collins etc.)
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Pharmacology and the Nursing Process NINTH EDITION Linda Lane Lilley, RN, PhD University Professor and Associate Professor Emeritus (Retired) School of Nursing Old Dominion University Norfolk, Virginia Shelly Rainforth Collins, PharmD President Drug Information Consultants Chesapeake, Virginia 2 Julie S. Snyder, MSN, RN-BC Lecturer School of Nursing, Regent University Virginia Beach, Virginia 3 Disclaimer This title includes additional digital media when purchased in print format. For this digital book edition, media content may not be included. 4 Table of Contents Cover image Title Page Disclaimer About the Authors Copyright Contributors to Teaching/Learning Resources Reviewers Preface Organization New to This Edition Additional Teaching/Learning Features Supplemental Resources 5 Acknowledgments We Welcome Your Feedback To the Student Learning Strategies Nursing Process Vocabulary Text Notation Enhanced Typeface Study Time Learning Styles Use of Applications Flash Cards Study Groups Chat Rooms and Discussion Groups Time Management Practice Questions Application of Pharmacology and Making Connections Studying for Tests Test-Taking Strategies Performance Evaluation Future Application 6 Part 1 Pharmacology Basics 1 The Nursing Process and Drug Therapy Overview of the Nursing Process Assessment Identification of Human Need Statements Planning: Outcome Identification Implementation Evaluation Key Points Critical Thinking Exercises Review Questions References 2 Pharmacologic Principles Overview Pharmaceutics Pharmacokinetics Pharmacodynamics Pharmacotherapeutics Pharmacognosy Pharmacoeconomics 7 Toxicology Summary Key Points Critical Thinking Exercises Review Questions References 3 Lifespan Considerations Overview Drug Therapy During Pregnancy Drug Therapy During Breastfeeding Considerations for Neonatal and Pediatric Patients Considerations for Older Adult Patients Nursing Process Key Points Critical Thinking Exercises Review Questions References 4 Cultural, Legal, and Ethical Considerations Cultural Considerations Legal Considerations 8 Ethical Considerations as Related to Drug Therapy and Nursing Practice Nursing Process Key Points Critical Thinking Exercises Review Questions References 5 Medication Errors Medication Errors Issues Contributing to Errors Preventing, Responding to, Reporting, and Documenting Medication Errors: a Nursing Perspective Errors Related to the Transition of Care Summary Key Points Critical Thinking Exercises Review Questions References 6 Patient Education and Drug Therapy Overview Assessment of Learning Needs Related to Drug Therapy 9 Human Need Statements Related to Learning Needs and Drug Therapy Planning: Outcome Identification as Related to Learning Needs and Drug Therapy Implementation Related to Patient Education and Drug Therapy Evaluation of Patient Learning Related to Drug Therapy Summary Key Points Critical Thinking Exercises Review Questions References 7 Over-the-Counter Drugs and Herbal and Dietary Supplements Over-the-Counter Drugs Herbals and Dietary Supplements Nursing Process Key Points Critical Thinking Exercises Review Questions References 8 Gene Therapy and Pharmacogenomics Overview 10 Basic Principles of Genetic Inheritance Discovery, Structure, and Function of DNA Gene Therapy Pharmacogenetics and Pharmacogenomics Application of the Nursing Process as Related to Genetic Principles Summary Key Points Critical Thinking Exercises Review Questions References 9 Photo Atlas of Drug Administration Preparing for Drug Administration Enteral Drugs Parenteral Drugs Topical Drugs References Part 2 Drugs Affecting the Central Nervous System 10 Analgesic Drugs Overview 11 Treatment of Pain in Special Situations Pharmacology Overview Opioid Drugs Drug Profiles Nonopioid and Miscellaneous Analgesics Drug Profiles Nursing Process Assessment Key Points Critical Thinking Exercises Review Questions References 11 General and Local Anesthetics Overview General Anesthetics Drug Profiles Drugs for Moderate Sedation Local Anesthetics Drug Profiles Neuromuscular Blocking Drugs Drug Profiles 12 Nursing Process Key Points Critical Thinking Exercises Review Questions References 12 Central Nervous System Depressants and Muscle Relaxants Overview Physiology of Sleep Benzodiazepines and Miscellaneous Hypnotic Drugs Drug Profiles Barbiturates Drug Profiles Over-the-Counter Hypnotics Muscle Relaxants Drug Profiles Nursing Process Key Points Critical Thinking Exercises Review Questions References 13 13 Central Nervous System Stimulants and Related Drugs Overview Attention-Deficit/Hyperactivity Disorder Narcolepsy Obesity Migraine Analeptic-Responsive Respiratory Depression Syndromes Drugs for Attention-Deficit/Hyperactivity Disorder and Narcolepsy Drug Profiles Anorexiants Drug Profiles Antimigraine Drugs Drug Profiles Drugs for Specific Respiratory Depression Syndromes: Analeptics Drug Profiles Nursing Process Key Points Critical Thinking Exercises Review Questions References 14 14 Antiepileptic Drugs Epilepsy Antiepileptic Drugs Drug Profiles Nursing Process Key Points Critical Thinking Exercises Review Questions References 15 Antiparkinson Drugs Indirect-Acting Dopaminergic Drugs Direct-Acting Dopamine Receptor Agonists Critical Thinking Exercises Review Questions References 16 Psychotherapeutic Drugs Anxiety Disorders Affective Disorders Psychotic Disorders Critical Thinking Exercises 15 Review Questions References 17 Substance Use Disorder Overview Opioids Stimulants Depressants Alcohol Nicotine Nursing Process Key Points Critical Thinking Exercises Review Questions References Part 3 Drugs Affecting the Autonomic Nervous System 18 Adrenergic Drugs Overview Sympathetic Nervous System Adrenergic Drugs 16 Drug Profiles Nursing Process Key Points Critical Thinking Exercises Review Questions References 19 Adrenergic-Blocking Drugs Overview Alpha Blockers Drug Profiles Beta Blockers Drug Profiles Nursing Process Key Points Critical Thinking Exercises Review Questions References 20 Cholinergic Drugs Overview Parasympathetic Nervous System 17 Cholinergic Drugs Drug Profiles Nursing Process Key Points Critical Thinking Exercises Review Questions References 21 Cholinergic-Blocking Drugs Parasympathetic Nervous System Cholinergic-Blocking Drugs Drug Profiles Nursing Process Key Points Critical Thinking Exercises Review Questions References Part 4 Drugs Affecting the Cardiovascular and Renal Systems 22 Antihypertensive Drugs Anatomy, Physiology, and Pathophysiology Overview 18 Pharmacology Overview Review of Autonomic Neurotransmission Adrenergic Drugs Drug Profiles Angiotensin-Converting Enzyme Inhibitors Drug Profiles Angiotensin II Receptor Blockers Drug Profile Calcium Channel Blockers Diuretics Vasodilators Drug Profiles Miscellaneous Antihypertensive Drugs Drug Profiles Nursing Process Key Points Critical Thinking Exercises Review Questions References 23 Antianginal Drugs Overview 19 Pharmacology Overview Nitrates and Nitrites Drug Profiles Beta Blockers Drug Profiles Calcium Channel Blockers Drug Profiles Drug Profile Summary of Antianginal Pharmacology Nursing Process Key Points Critical Thinking Exercises Review Questions References 24 Heart Failure Drugs Overview Pharmacology Overview Angiotensin-Converting Enzyme Inhibitors Drug Profile Angiotensin II Receptor Blockers Drug Profile 20 Angiotensin Receptor-Neprilysin Inhibitors Drug Profile Beta Blockers Aldosterone Antagonists Drug Profiles Phosphodiesterase Inhibitors Drug Profile Cardiac Glycosides Drug Profiles Nursing Process Key Points Critical Thinking Exercises Review Questions References 25 Antidysrhythmic Drugs Dysrhythmias and Normal Cardiac Electrophysiology Antidysrhythmic Drugs Drug Profiles Nursing Process Key Points Critical Thinking Exercises 21 Review Questions References 26 Coagulation Modifier Drugs Overview Pharmacology Overview Anticoagulants Drug Profiles Antiplatelet Drugs Drug Profiles Thrombolytic Drugs Drug Profile Antifibrinolytic Drugs Drug Profiles Nursing Process Key Points Critical Thinking Exercises Review Questions References 27 Antilipemic Drugs Overview 22 Lipids and Lipid Abnormalities Atherosclerotic Plaque Formation Cholesterol and Coronary Heart Disease Hyperlipidemias and Treatment Guidelines Hydroxymethylglutaryl–Coenzyme a Reductase (HMG-CoA Reductase) Inhibitors Drug Profiles Bile Acid Sequestrants Drug Profile Niacin Drug Profile Fibric Acid Derivatives Drug Profiles Miscellaneous Antilipemic Drugs Psck-9 Inhibitors Nursing Process Key Points Critical Thinking Exercises Review Questions References 28 Diuretic Drugs 23 Overview Pharmacology Overview Carbonic Anhydrase Inhibitors Drug Profile Loop Diuretics Summary of Major Drug Effects of Loop Diuretics Drug Profile Osmotic Diuretics Drug Profile Potassium-Sparing Diuretics Drug Profiles Thiazides and Thiazide-Like Diuretics Drug Profiles Nursing Process Key Points Critical Thinking Exercises Review Questions References 29 Fluids and Electrolytes Overview Crystalloids 24 Drug Profile Colloids Drug Profiles Blood Products Drug Profiles Physiology of Electrolyte Balance Potassium Drug Profiles Sodium Drug Profiles Nursing Process Key Points Critical Thinking Exercises Review Questions References Part 5 Drugs Affecting the Endocrine and Reproductive Systems 30 Pituitary Drugs Endocrine System Pituitary Drugs Drug Profiles 25 Nursing Process Key Points Critical Thinking Exercises Review Questions References 31 Thyroid and Antithyroid Drugs Thyroid Function Pathophysiology of Hypothyroidism Pathophysiology of Hyperthyroidism Thyroid Replacement Drugs Drug Profile Antithyroid Drugs Drug Profile Nursing Process Key Points Critical Thinking Exercises Review Questions References 32 Diabetes Drugs Insulins 26 Oral Diabetes Drugs Injectable Diabetes Drugs Sodium Glucose Cotransporter Inhibitors (SGLT2 Inhibitors) Glucose-Elevating Drugs Critical Thinking Exercises Review Questions References 33 Adrenal Drugs Adrenal System Adrenal Drugs Drug Profiles Nursing Process Key Points Critical Thinking Exercises Review Questions References 34 Women's Health Drugs Female Sex Hormones Drug Profile Drug Profiles 27 Contraceptive Drugs Drug Profile Drugs for Osteoporosis Drug Profiles Drugs Related to Pregnancy, Labor, Delivery, and the Postpartum Period Drug Profile Drug Profiles Nursing Process Key Points Critical Thinking Exercises Review Questions References 35 Men's Health Drugs Male Reproductive System Androgens and Other Drugs Pertaining to Men's Health Drug Profiles Nursing Process Key Points Critical Thinking Exercises Review Questions 28 References Part 6 Drugs Affecting the Respiratory System 36 Antihistamines, Decongestants, Antitussives, and Expectorants Overview Antihistamines Drug Profiles Decongestants Drug Profile Antitussives Drug Profiles Expectorants Drug Profile Nursing Process Key Points Critical Thinking Exercises Review Questions References 37 Respiratory Drugs Bronchodilators Nonbronchodilating Respiratory Drugs 29 Review Questions References Part 7 Antiinfective and Antiinflammatory Drugs 38 Antibiotics Part 1 Antibiotics Beta-Lactam Antibiotics Macrolides Tetracyclines Critical Thinking Exercises Review Questions References 39 Antibiotics Part 2 Overview Pathophysiology of Resistant Infections Aminoglycosides Drug Profiles Quinolones Drug Profiles Miscellaneous Antibiotics Drug Profiles 30 Nursing Process Key Points Critical Thinking Exercises Review Questions References 40 Antiviral Drugs General Principles of Virology Overview of Viral Illnesses and Their Treatment Herpes Simplex Virus and Varicella-Zoster Virus Infections Hepatitis Antivirals (Non–Human Immunodeficiency Virus) Drug Profiles HIV Infection and AIDS Drugs Used to Treat Human Immunodeficiency Virus Infection Drug Profiles Nursing Process Key Points Critical Thinking Exercises Review Questions References 31 41 Antitubercular Drugs Pathophysiology of Tuberculosis Antitubercular Drugs Drug Profiles Nursing Process Key Points Critical Thinking Exercises Review Questions References 42 Antifungal Drugs Fungal Infections Antifungal Drugs Drug Profiles Nursing Process Key Points Critical Thinking Exercises Review Questions References 43 Antimalarial, Antiprotozoal, and Anthelmintic Drugs Overview 32 Pathophysiology of Malaria Antimalarial Drugs Drug Profiles Other Protozoal Infections Antiprotozoal Drugs Drug Profiles Helminthic Infections Anthelmintic Drugs Drug Profiles Nursing Process Key Points Critical Thinking Exercises Review Questions References 44 Antiinflammatory and Antigout Drugs Overview Nonsteroidal Antiinflammatory Drugs Drug Profiles Antigout Drugs Drug Profiles Nursing Process 33 Key Points Critical Thinking Exercises Review Questions References Part 8 Chemotherapeutic Drugs and Biologic and Immune Modifiers 45 Antineoplastic Drugs Part 1 Overview Targeted Drug Therapy Cell Cycle–Specific Antineoplastic Drugs Drug Profiles Drug Profiles Drug Profiles Drug Profiles Nursing Process Key Points Critical Thinking Exercises Review Questions References 46 Antineoplastic Drugs Part 2 34 Overview Cell Cycle–Nonspecific Antineoplastic Drugs Drug Profiles Drug Profiles Miscellaneous Antineoplastics Drug Profiles Hormonal Antineoplastics Nursing Process Key Points Critical Thinking Exercises Review Questions References 47 Biologic Response–Modifying and Antirheumatic Drugs Overview of Immunomodulators Pharmacology Overview Drug Profiles Drug Profiles Drug Profiles Drug Profiles Drug Profiles Nursing Process 35 Key Points Critical Thinking Exercises Review Questions References 48 Immunosuppressant Drugs Immune System Immunosuppressant Drugs Drug Profiles Nursing Process Key Points Critical Thinking Exercises Review Questions References 49 Immunizing Drugs Immunity and Immunization Immunizing Drugs Drug Profiles Nursing Process Key Points Critical Thinking Exercises 36 Review Questions References Part 9 Drugs Affecting the Gastrointestinal System and Nutrition 50 Acid-Controlling Drugs Overview Acid-Related Pathophysiology Antacids Drug Profiles H2 Receptor Antagonists Drug Profiles Proton Pump Inhibitors Drug Profiles Miscellaneous Acid-Controlling Drugs Drug Profiles Nursing Process Key Points Critical Thinking Exercises Review Questions References 37 51 Bowel Disorder Drugs Overview Antidiarrheals Drug Profiles Laxatives Drug Profiles Drugs for Irritable Bowel Syndrome Nursing Process Critical Thinking Exercises Review Questions References 52 Antiemetic and Antinausea Drugs Nausea and Vomiting Antiemetic Drugs Drug Profiles Nursing Process Key Points Critical Thinking Exercises Review Questions References 38 53 Vitamins and Minerals Overview Pharmacology Overview Fat-Soluble Vitamins Drug Profile Drug Profiles Drug Profile Drug Profile Water-Soluble Vitamins Drug Profile Drug Profile Drug Profile Drug Profile Drug Profile Drug Profile Minerals Drug Profile Drug Profile Drug Profile Nursing Process Key Points 39 Critical Thinking Exercises Review Questions References 54 Anemia Drugs Erythropoiesis Types of Anemia Erythropoiesis-Stimulating Drugs Drug Profiles Iron Drug Profiles Folic Acid Drug Profile Other Anemia Drugs Nursing Process Key Points Critical Thinking Exercises Review Questions References 55 Nutritional Supplements Overview 40 Enteral Nutrition Drug Profiles Parenteral Nutrition Drug Profiles Nursing Process Key Points Critical Thinking Exercises Review Questions References Part 10 Dermatologic, Ophthalmic, and Otic Drugs 56 Dermatologic Drugs Overview Pharmacology Overview Antimicrobials Drug Profiles Drug Profiles Drug Profiles Anesthetic, Antipruritic, and Antipsoriatic Drugs Drug Profiles Miscellaneous Dermatologic Drugs Drug Profiles 41 Wound Care Drugs Skin Preparation Drugs Nursing Process Key Points Critical Thinking Exercises Review Questions References 57 Ophthalmic Drugs Overview Pharmacology Overview Antiglaucoma Drugs Drug Profiles Drug Profiles Drug Profiles Drug Profile Drug Profiles Drug Profile Antimicrobial Drugs Drug Profiles Antiinflammatory Drugs 42 Drug Profiles Topical Anesthetics Drug Profile Diagnostic Drugs Drug Profiles Miscellaneous Drugs Drug Profiles Nursing Process Key Points Critical Thinking Exercises Review Questions References 58 Otic Drugs Overview Treatment of Ear Disorders Antibacterial and Antifungal Otic Drugs Drug Profiles Earwax Emulsifiers Drug Profile Nursing Process Key Points 43 Critical Thinking Exercises Review Questions References Appendix Pharmaceutical Abbreviations Answers to Review Questions Index Special Features 44 About the Authors Linda Lane Lilley RN, PhD Linda Lilley received her diploma from Norfolk General School of Nursing, BSN from the University of Virginia, Master of Science (Nursing) from Old Dominion University, and PhD in Nursing from George Mason University. As an Associate Professor Emeritus and University Professor at Old Dominion University, her teaching experience in nursing education spans over 25 years, including almost 20 years at Old Dominion. Linda's teaching expertise includes drug therapy and the nursing process, adult nursing, physical assessment, fundamentals in nursing, oncology nursing, nursing theory, and trends in health care. The awarding of the university's most prestigious title of University Professor reflects her teaching excellence as a tenured faculty member. She has also been a two-time university nominee for the State Council of Higher Education in Virginia award for excellence in teaching, service, and scholarship. Linda received the 2012 Distinguished Nursing Alumni Award from Old Dominion University School of Nursing 45 for her “continued work on the successful pharmacology textbook published by Elsevier” and to recognize her “extraordinary work and the impact [the book] has had on baccalaureate education.” While at Old Dominion University, Linda mentored and taught undergraduate and graduate students as well as registered nurses returning for their BSN. Linda authored the MED ERRORS column for the American Journal of Nursing between 1994 and 1999, as well as numerous other peer-reviewed, published articles in professional nursing journals. Since retiring in 2005, Linda continues to be active in nursing, serving as a member on dissertation committees with the College of Health Sciences and maintaining membership and involvement in numerous professional and academic organizations. Since January of 2014, Dr. Lilley continues to serves on the volunteer review panel for the monthly newsletter publication Nurse Advise-ERR (ISMP affiliated; the ISMP [Institute for Safe Medication Practices] is a nonprofit organization educating the healthcare community and consumers about safe medication practices). Linda has served as a consultant with school nurses in the city of Virginia Beach and as a member on the City of Virginia Beach's Health Advisory Board. Linda also served as an appointed member on the national advisory panel on medication error prevention with the U.S. Pharmacopeia in Rockville, Maryland. She continues to educate nursing students and professional nurses about drug therapy and the nursing process and speaks on the topics of drug therapy, safe medication use, humor and healing, and grief and loss. Shelly Rainforth Collins PharmD Shelly Rainforth Collins received her Doctor of Pharmacy degree 46 from the University of Nebraska, College of Pharmacy in 1985, with High Distinction. She then completed a clinical pharmacy residency at Memorial Medical Center of Long Beach in Long Beach, California. She worked as a pediatric clinical pharmacist (neonatal specialist) at Memorial Medical Center before moving to Mobile, Alabama, where she was the Assistant Director of Clinical Pharmacy Services at Mobile Infirmary Medical Center. After moving to Chesapeake, Virginia, she served as the Clinical Pharmacy Specialist/Coordinator of Clinical Pharmacy Services at Chesapeake Regional Medical Center in Chesapeake, Virginia for 19 years. Her practice focused on developing and implementing clinical pharmacy services as well as medication safety and Joint Commission medication management standards and national patient safety goals. She is president of Drug Information Consultants, a business offering consultation and expert witness review for attorneys on medical malpractice cases. She holds certifications in Medication Therapy Management, Anticoagulation Management, and Immunizations. Shelly was awarded the Clinical Pharmacist of the Year Award in 2007 from the Virginia Society of Healthsystem Pharmacists. She led a multidisciplinary team that won the Clinical Achievement of the Year Award from George Mason University School of Public Health in 2007 for promoting safety with narcotics in patients with sleep apnea; this program has also received national recognition. She was awarded the Service Excellence Award from Chesapeake Regional Medical Center. Shelly's professional affiliations include the American Society of Healthsystem Pharmacists, the Virginia Society of Healthsystem Pharmacists, and the American Pharmacists Association. 47 Julie S. Snyder MSN, RN-BC Julie Snyder received her diploma from Norfolk General Hospital School of Nursing and her BSN and MSN from Old Dominion University. After working in medical-surgical nursing, she worked in nursing staff development and community education. Later, she transferred to the academic setting and taught fundamentals of nursing, pharmacology, physical assessment, and adult medicalsurgical nursing at a university school of nursing. Julie has recently worked as a Quality Initiative Coordinator and a Clinical Nurse Educator in a local hospital. She is now a Lecturer at the School of Nursing of Regent University in Virginia Beach, Virginia. She has been certified by the ANCC in Nursing Continuing Education and Staff Development and currently holds ANCC certification in Medical-Surgical Nursing. She is a member of Sigma Theta Tau International and was inducted into Phi Kappa Phi as Outstanding Alumni for Old Dominion University. She has worked for Elsevier as a reviewer, ancillary writer, and author since 1997. Julie's professional service has included serving on the Virginia Nurses' Association Continuing Education Committee, serving as Educational Development Committee chair for the Epsilon Chi chapter of Sigma Theta Tau, serving as an item writer for the ANCC, working with a regional hospital educators' group, and serving as a consultant on various projects for local hospital education departments. In addition, she has conducted pharmacology review classes for recent nursing graduates. 48 Copyright PHARMACOLOGY AND THE NURSING PROCESS, NINTH EDITION ISBN: 978-0-323-52949-5 Copyright © 2020 by Elsevier Inc. All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, recording, or any information storage and retrieval system, without permission in writing from the publisher. Details on how to seek permission, further information about the Publisher's permissions policies, and our arrangements with organizations such as the Copyright Clearance Center and the Copyright Licensing Agency can be found at our website: www.elsevier.com/permissions. This book and the individual contributions contained in it are protected under copyright by the Publisher (other than as may be noted herein). Notice Practitioners and researchers must always rely on their own experience and knowledge in evaluating and using any information, methods, compounds or experiments described herein. Because of rapid advances in the medical sciences, in particular, independent verification of diagnoses and drug dosages should be made. To the fullest extent of the law, no responsibility is assumed by Elsevier, authors, editors or contributors for any injury and/or 49 damage to persons or property as a matter of products liability, negligence or otherwise, or from any use or operation of any methods, products, instructions, or ideas contained in the material herein. Previous editions copyrighted 2017, 2014, 2011, 2007, 2005, 2001, 1999, and 1996. International Standard Book Number: 978-0-323-52949-5 Executive Content Strategist: Sonya Seigafuse Senior Content Development Specialist: Laura Goodrich Publishing Services Manager: Julie Eddy Book Production Specialist: Clay S. Broeker Design Direction: Amy Buxton Printed in Canada Last digit is the print number: 9 8 7 6 5 4 3 2 1 3251 Riverport Lane St. Louis, Missouri 63043 50 Contributors to Teaching/Learning Resources Critical Thinking Questions Julie S. Snyder MSN, RN-BC Lecturer School of Nursing, Regent University Virginia Beach, Virginia Key Points—Downloadable Margaret Slota DNP, RN, FAAN Associate Professor and Director of DNP and Graduate Nursing Leadership Programs Carlow University School of Nursing Pittsburgh, Pennsylvania PowerPoint® Slides Margie Francisco EdD, MSN, RN Nursing Professor Health Division Illinois Valley Community College Oglesby, Illinois Review Questions for the NCLEX® Examination 51 Stephanie Evans PhD, RN, CPNP-PC, CLC Assistant Professor Nursing Texas Christian University Fort Worth, Texas Test Bank Julie S. Snyder MSN, RN-BC Lecturer School of Nursing, Regent University Virginia Beach, Virginia Unfolding Case Studies Stephanie Evans PhD, RN, CPNP-PC, CLC Assistant Professor Nursing Texas Christian University Fort Worth, Texas 52 Reviewers Yvonne L. Chapman DNP, FNP-BC, CNE, RN Nursing Faculty Nursing Kalamazoo Valley Community College Kalamazoo, Michigan Mary P. Cousineau MS, RN, PPCNP-BC, CNE Adjunct Nursing Faculty Nursing and Allied Health Hartnell College Salinas, California Bethany Ebelhar MSN, RN Associate Professor Owensboro Community and Technical College Owensboro, Kentucky Cynthia Theys MSN, RN, MSOLQ Associate Dean Health Sciences and Education Northeast Wisconsin Technical College Green Bay, Wisconsin 53 Preface Now in its ninth edition, Pharmacology and the Nursing Process provides the most current and clinically relevant nursing pharmacology content in a visually appealing, understandable, and practical format. The accessible size, clear writing style, and fullcolor design of Pharmacology and the Nursing Process are ideal for today's busy nursing student. The book not only presents drug information that nursing student needs to know but also provides information on what professional nurses may encounter during drug administration in a variety of health care settings, including accounts of real-life medication errors and tips for avoiding those errors. Edition after edition, the book has become increasingly inviting and engaging for the adult learner to read and study. Features that help set the book apart include: • A focus on the role of prioritization in nursing care • A strong focus on drug classes to help students acquire a better knowledge of how various drug classes work in the body, allowing them to apply this knowledge to individual drugs • Ease of readability to make this difficult content more understandable • Integrated learning strategies content that helps students understand and learn the particularly demanding subject of pharmacology while also 54 equipping them with tools that they can use in other courses and as lifelong learners who are building an evidence-based practice For this edition, the author team has continued to focus closely on providing the most “need-to-know” information, enhancing readability, and emphasizing the nursing process and prioritization throughout. Sharing the goal of creating a nursing pharmacology textbook that is not only academically rigorous but also practical and easy to use, the authors bring together a unique combination of experience. The author team is comprised of an Associate Professor Emeritus with a PhD in nursing and more than 25 years of teaching experience, a clinical pharmacist with a PharmD and over 30 years of experience in hospital and long-term care pharmacy practice, and a nurse educator who holds a MSN in nursing education and has 30 years of teaching experience. Organization This book includes 58 chapters presented in 10 parts, organized by body system. The 9 “concepts” chapters in Part 1 lay a solid foundation for the subsequent drug units and address the following topics: • The nursing process and drug therapy • Pharmacologic principles • Lifespan considerations related to pharmacology • Cultural, legal, and ethical considerations • Preventing and responding to medication errors • Patient education and drug therapy • Over-the-counter drugs and herbal and dietary supplements • Gene therapy and pharmacogenomics • A photo atlas that describes drug administration 55 techniques, including more than 100 drawings and photographs Parts 2 through 10 present pharmacology and nursing management in a time-tested body systems/drug function framework. This approach facilitates learning by grouping functionally related drugs and drug groups. It provides an effective means of integrating the content into medical-surgical/adult health nursing courses or for teaching pharmacology in a separate course. The 49 drug chapters in these 9 parts constitute the main portion of the book. Drugs are presented in a consistent format with an emphasis on drug classes and key similarities and differences among the drugs in each class. Each chapter is subdivided into two discussions, beginning with (1) a brief overview of anatomy, physiology, and pathophysiology and a complete discussion of pharmacology, followed by (2) a comprehensive yet succinct application of the nursing process. Pharmacology is presented for each drug group in a consistent format: • Mechanism of Action and Drug Effects • Indications • Contraindications • Adverse Effects (often including Toxicity and Management of Overdose) • Interactions • Dosages Drug class discussions conclude with Drug Profiles—brief narrative “capsules” of individual drugs in the class or group, including Pharmacokinetics tables for each drug. High-alert medications are identified with a symbol to increase awareness of high-alert medications. The pharmacology section is followed by a Nursing Process discussion that relates to the entire drug group. This nursing content is covered in the following, familiar nursing process format: 56 • Assessment • Human Need Statements • Planning (including Goals and Outcome Criteria) • Implementation • Evaluation At the end of each Nursing Process section is a Patient-Centered Care: Patient Teaching section that summarizes key points for nursing students and/or practicing nurses to include in the education of patients about their medications. This section focuses on teaching how the drugs work, possible interactions, adverse effects, and other information related to the safe and effective use of the drug(s). The role of the nurse as patient educator and advocate continues to grow in importance in professional practice, so there is emphasis on this key content in each chapter in this edition. This arrangement of content can be especially helpful to faculty who teach pharmacology through an integrated approach because it helps the student identify key content and concepts. New to This Edition To further improve the hallmark readability and user-friendliness of Pharmacology and the Nursing Process, each line of the text has been edited to improve readability. The ninth edition of Pharmacology and the Nursing Process continues to feature additional Quality and Safety Education for Nurses (QSEN) competencies by providing the following: • Use of human need theory with human need statements to replace previously identified nursing diagnoses included in the Nursing Process sections of each chapter • Revised case studies with the relevant QSEN content included 57 • Selected case studies featuring collaboration and teamwork content • Additional Safety and Quality Improvement: Preventing Medication Errors boxes • Further explanation and discussion of the QSEN initiative as it relates to safety and quality of patient care included in the Medication Errors chapter and in boxes throughout the book The QSEN initiative is also highlighted in this edition's TEACH for Nurses Lesson Plans (see Supplemental Resources). The pharmacology and nursing content in each of the 58 chapters has been thoroughly revised and critically reviewed by nursing instructors, practicing nurses, and a clinical pharmacist to reflect the latest drug information and nursing content. Key updates include: • New seizure classifications • New oral anticoagulant reversal agents • Black box warnings added in bold to highlight safety • Recently approved drugs that are included and discussed • Substance abuse terminology changing to Substance Use Disorder • Revised Review Questions at the end of each chapter, including alternate-item format and dosage calculation questions to assist the student in preparation for the NCLEX® examination. Additional Teaching/Learning 58 Features The book also includes a variety of innovative teaching/learning features that prepare the student for important content to be covered in each chapter and encourage review and reinforcement of that content. Chapter opener features include the following: • Learning Objectives • Summary of Drug Profiles in the chapter, with page number references • Key terms with definitions (key terms being in bold blue type throughout the narrative to emphasize this essential terminology) The following features appear at the end of each chapter: • Patient Teaching Tips related to drug therapy • Key Points summarizing important chapter content • Critical Thinking Questions, with answer guidelines provided on the Evolve website • Review Questions, with answers provided in the back of the book for quick and easy review • List of Evolve Resources available to students In addition to the special boxes listed previously, other special features that appear throughout the text include: • Case Studies, with answer guidelines provided on the Evolve website • Dosages tables listing generic and trade names, pharmacologic class, usual dosage ranges, and indications for the drugs 59 For a more comprehensive listing of the special features, please see the inside back cover of the book. Supplemental Resources A comprehensive ancillary package is available to instructors (and their students) who adopt Pharmacology and the Nursing Process. The following supplemental resources have been thoroughly revised for this edition and can significantly assist teaching and learning of pharmacology. Study Guide The carefully prepared student workbook includes the following: • Student Study Tips that reinforce the Learning Strategies in the text and provide a “how to” guide to applying test-taking strategies • Worksheets for each chapter, with NCLEX®style questions (now with more application-based, alternate-item, and dosage calculation questions), critical thinking and application questions, and other activities • Case Studies followed by related critical thinking questions • An updated Overview of Dosage Calculations with helpful tips for calculating dosages, sample drug labels, practice problems, and a quiz • Answers to all questions (provided in the back of the book) to facilitate self-study Evolve Website Located at http://evolve.elsevier.com/Lilley/, the Evolve website for this 60 book includes the following: For students: • More than 600 NCLEX® Examination Review Questions • Printable, expanded Key Points for each chapter • Content Updates • Answers to Case Studies from the book For instructors: • TEACH for Nurses Lesson Plans that focus on the most important content from each chapter and provide innovative strategies for student engagement and learning. These new Lesson Plans include strategies for integrating nursing curriculum standards (QSEN, concept-based learning, and the BSN essentials), links to all relevant student and instructor resources, and an original instructor-only Case Study in each chapter. • ExamView Test Bank that features more than 800 test questions (including alternate-item questions) with rationales and answers coded for NCLEX® Client Needs category, nursing process step, and cognitive level (new and old Bloom's taxonomy). The robust ExamView testing application, provided at no cost to faculty, allows instructors to create new tests; edit, add, and delete test questions; sort questions by NCLEX® Client Needs category, cognitive level, and 61 nursing process step; and administer and grade tests online, with automated scoring and gradebook functionality. • PowerPoint Lecture Slides consist of more than 2100 customizable text slides for instructors to use in lectures. • Audience Response System Questions (three or more discussion-oriented questions per chapter for use with i>Clicker and other systems) are folded into these presentations. • An Image Collection with more than 200 fullcolor images from the book for instructors to use in lectures. • Access to all student resources listed above. Pharmacology Online Pharmacology Online for Pharmacology and the Nursing Process, ninth edition, is a dynamic, unit-by-unit online course that includes interactive self-study modules, a collection of interactive learning activities, and a media-rich library of supplemental resources. • Self-Study Modules go beyond the basic principles of pharmacology, with animations and NCLEX® Examination–style questions to help students assess their understanding of pharmacology concepts. • Interactive Case Studies immerse students in trueto-life scenarios that require them to make important choices in patient care and patient teaching. • “Roadside Assistance” video clips use humor and 62 analogy in a uniquely fun and engaging way to teach key concepts. • Interactive Learning Activities, Practice Quizzes for the NCLEX® Examination, and more are also included. 63 Acknowledgments This book truly has been a collaborative effort. We wish to thank the instructors and students who provided input on an ongoing basis throughout the development of the current and previous editions. Many thanks and appreciation for the hard work, support and dedication shown by Laura Goodrich, Senior Content Development Specialist; Sonya Seigafuse, Executive Content Strategist; and Clay Broeker, Book Production Specialist on this current edition. Their attention to detail, conscientiousness and professionalism has been exhibited in all of their interactions with us, the authors. Clay Broeker has been our production specialist for numerous editions, and we are so very appreciative of his continued work, dedication, and support on the ninth edition. He has always guided us with patience and professionalism through to publication on these projects. Special thanks to Kristin Geen, Jamie Blum, and Charlene Ketchum, who worked diligently and supported us on earlier editions. Laura Jaroneski lent her study skills expertise and has updated the unique and appropriate Learning Strategies features for students; for her collaboration, we are most grateful. Finally, we thank Joe Albanese for his contributions to the first edition of the book, Bob Aucker for his contributions to the first three editions, and Scott Harrington for contributions through the sixth edition. Linda thanks her daughter Karen for her unwavering and constant support. Long hours and time spent researching and writing has preempted time with family, but Karen has always understood. Linda wishes to dedicate this book to Karen Leanne Lilley Harris because of her continued inspiration, encouragement, 64 and support for all professional endeavors and accomplishments. The memory of Linda's parents, John and Thelma Lane, who passed away during the fourth edition, and in-laws J.C. and Mary Anne Lilley, who passed away during the fifth and sixth editions, has continued to provide inspiration and a sense of pride in all her work. Students and graduates of Old Dominion University School of Nursing have been eager to provide feedback and support, beginning with the class of 1990 and continuing through the class of 2005. Without their participation, the book would not have been so user-friendly and helpful to students embarking upon their study of drug therapy. Linda attributes her successes and accomplishments to a strong sense of purpose, faith, and family as well as a continued appreciation and value for the light-hearted side of life. To Jibby Baucom, Linda offers many thanks, because without her recommendation to Mosby, Inc. back in the 1990s, the book would never have been developed. Robin Carter, Kristin Geen, Lee Henderson, Jamie Blum, and Jackie Twomey have also been significant resources and more than just editors with Elsevier; they have been sources of strength and encouragement. Their excellent work ethic, positivity, and calming natures will be forever appreciated. The fifth through ninth editions have also involved Clay Broeker, who has been a tremendous resource in dealing with production issues; his contributions to all of these editions have been strong, exceptional, and forward-thinking. Elsevier has shared some of its best employees with Linda beginning with the first day of the first edition; for that, Linda is most thankful and extremely grateful. Shelly wishes to dedicate this edition to her daughter Kristin Collins of Chesapeake, Virginia, and to her father Charles Rainforth of Hastings, Nebraska, the two most important people in her life. You both have been an inspiration, a support system, and most importantly, a source of constant love. Kristin, it has been such a joy watching you grow into the wonderful woman you have become. You are an amazing educator, and your students are, and will continue to be, inspired by your passion, grace, and dedication. I am so very proud of you!! The memory of Shelly's mother, Rogene Rainforth, who passed away during the seventh edition, continues to provide a sense of pride and love. Shelly wishes to thank her 65 brother, Randy Rainforth, for supporting their father when distance separates the family. Shelly would also like to thank Linda Lilley and Julie Snyder for giving her the opportunity to be affiliated with such a wonderful book. To the amazing editorial staff at Elsevier, thank you. Julie wishes to dedicate this edition to her husband, Jonathan, for his love and patience during long hours of revisions. She thanks her parents Willis and Jean Simmons and her daughter Emily Martin and son-in-law Randy Martin for their unfailing love, support, and encouragement. She appreciates the support of the staff nurses who work alongside and provide leadership for our nursing students in the clinical settings. Thanks also to Rick Brady for his previous assistance with the photo shoot for the Photo Atlas of Drug Administration and to Scott Brown for his work in updating the photographs in the current edition. Julie also thanks the administration of Chesapeake Regional Healthcare and the 2017 RN Residents (Divina Mendoza, Sara Allison, Napre Hayag, Jennifer Duty, and Rina Nina Fetalvaro) for lending the facility and their time for this edition's photo shoot. The support and the encouragement of family, friends, and colleagues are vital to projects like this. Thanks also to Shelly Rainforth Collins for her clinical insight and endless willingness to address questions. Julie continues to deeply appreciate the encouragement, mentoring, support, and friendship of Dr. Linda L. Lilley over the years; her drive to make this book a success is inspirational. Most importantly, Julie gives thanks to God, our source of hope and strength. Finally, to those who teach, although your work may seem to go unnoticed or unappreciated, your impact will always be remembered through the accomplishments of your students. Thank you for teaching our future nurses. We Welcome Your Feedback We always welcome comments from instructors and students who use this book so that we may continue to make improvements and be responsive to your needs in future editions. Linda Lane Lilley 66 Shelly Rainforth Collins Julie S. Snyder 67 To the Student Learning Strategies Opening your pharmacology textbook and glancing at the table of contents can seem overwhelming. You may wonder how you ever will be able remember so much information as well as the best approach in tackling such a daunting topic. The good news is that there are many learning strategies available to help you not only learn about pharmacology but also apply this knowledge to the nursing care of patients. To the learner, as the title of the book implies, pharmacology is very important to the nursing process. You will come to understand that learning in nursing is not about memorization but rather about application of learning. While there will be many times when memorization is required to begin to understand a new field of knowledge, the ultimate goal will always be to take your learning to a higher level. Learning strategies will be presented here that will guide you with techniques and suggestions on how to define and clarify the way you study and learn so that it will become second nature to transform your thinking into deeper, long-term learning with subsequent application to your professional nursing practice. As you begin your nursing education, you will soon realize that learning does not stop once you receive your degree and pass your state-licensing exam. As a professional nurse, you will come to understand that new information is always being added in the medical, pharmacology, and nursing professions. In the area of pharmacology, there are always new drugs being adopted, as well 68 as discontinued, for use by the US Food and Drug Administration. The strategies that you learn here can be used again and again to assist you in remaining current in new discoveries, new information, and new standards of practice within the nursing profession. You must be an active participant in your learning. Your instructor/faculty member acts more like a guide that assists you in attaining your fullest potential, allowing you to see the bigger picture or concept being taught. When students are taught this way, they gain more from their lessons because they are putting their learning into action. Also, that learning becomes embedded in their long-term memory because it is connected with a more complex thought process and has associated actions. You will need to be an active participant if you wish to fully comprehend and be able to apply pharmacology to your nursing knowledge/practice. Nurses spend a large part of their day giving medications to their patients. Anybody can open a pill packet, drop the pill in a cup, and give it to a person. However, safe medication administration demands an enormous amount of knowledge and understanding about why a patient is receiving a medication, specific actions that need to be taken before you give the medication, expected outcomes anticipated from the dose of medication, and specific patient teaching needs. Other important things to know prior to giving medications include how to perform drug calculations for the correct dosage and understanding the possible side effects or contraindications of the medication. As you read your pharmacology textbook and listen to your instructors teaching on the subject, you will begin to understand why learning pharmacology is more than just memorizing drug facts. Nursing Process In Chapter 1, you are introduced to the five phases of the Nursing Process. Throughout this textbook, you will see the nursing process applied to each category of drugs. This is a very important concept for you to understand. As you will recall from the introduction on learning strategies, administering medications to patients involves 69 more that the physical act of giving medications. The nurse needs to know the rationale and apply critical thinking with each patient encounter. The nursing process is a way to ensure that medications are administered accurately and safely. Nurses effortlessly use the nursing process every day, and students who are new to the nursing process learn best by using it frequently. Assessment Every patient encounter begins with an Assessment. As you are learning pharmacology, the importance of the assessment will become clear. You will want to ask yourself some questions: Why is this drug being prescribed for this patient? What symptoms does the patient have? What assessments do I need to perform prior to administering the medication (e.g., checking the patient's blood pressure or laboratory values)? Does the patient have any allergies to this medication? Has the patient taken this medication before? Human Need Statements Each patient will receive a Human Need Statement based on the assessment. These human need statements relate to the medical condition, such as freedom from pain, related to hip surgery. There are also human need statements related to the actual medication the patient is receiving, such as altered safety needs, risk for injury, related to possible adverse reactions to drugs altering blood clotting. After the human need statement is identified, the nurse will administer the medication to relieve the pain from hip surgery; the medication administration will be part of the implementation. In the second example, the medication administration will be critically evaluated to watch for the adverse effects of altered blood clotting. Planning Once you have established the human need statement, you need to decide on a Plan of care for the patient. What is the outcome that you want the patient to achieve? For our first example, pain relief is an appropriate outcome. It may further be defined by the pain level 70 (e.g., less than 5 out of 10 on the pain scale). For the second example, the outcome would state that the patient not experience any bleeding episodes. As explained in Chapter 1, these outcomes will be patient specific and have a time frame associated with them. Implementation With Implementation, you devise the actions or interventions that will provide the means in which the patient will achieve the outcome. For the patient with the human need of freedom from pain, an appropriate intervention would be to provide pain medication as prescribed. For the patient with a risk of bleeding, educating the patient about signs and symptoms of unusual bleeding would be appropriate. In these two examples, you see that implementation may be something we do for/with the patient, including patient education. Patient education is a very important component of pharmacology and the nursing process. Evaluation The last step of the nursing process is Evaluation. This is when you look at the outcomes and determine the effectiveness of the implementation phase. Did the patient with hip pain obtain relief from the administration of the pain medication? Did the patient at risk for bleeding have any episodes of bleeding and/or did he or she understand the teaching provided? If the outcome was not met, you will need to reevaluate the outcome statement and/or the interventions. Now you can see how the nursing process is an ongoing and constantly evolving process. Vocabulary Learning pharmacology in nursing means that there is an abundance of new terminology that you, the student, will encounter in your reading. It is important that you study the vocabulary so that you will have a deeper understanding of the content being taught. You may already be familiar with some of the vocabulary from other courses. Each chapter opens with a list of 71 Key Terms—significant vocabulary that will be introduced in that chapter. Oftentimes these words will appear in future chapters, so it is imperative that time is spent not just memorizing the terms but putting the terms into use and applying their meaning. Remember that application is important in nursing. The vocabulary words will appear in the text in blue boldface font, alerting you to the fact that it is a key term. Each vocabulary word is defined in the Key Terms section at the beginning of the chapter. When you see the word again in the content of the chapter, it is further defined either by explanation or application. For example, in Chapter 19, the term first-dose phenomena is defined as a severe and sudden drop in blood pressure after the administration of the first dose of an alpha-adrenergic blocker. When you see the term in the text, it is used under the heading “adverse effects,” so it is helpful for you to realize that the first-dose phenomena is not something good. It is further explained in the text that this adverse effect may cause patients to fall or pass out. This example demonstrates that when you are learning a key term, it is helpful to fully comprehend the implications and application to nursing practice. Taking your learning further, you may now associate this term with patient safety and the human need statement of “Altered need for safety, risk for falls.” Suddenly, a simple key term means so much more to you as a student. You can now see the application to the nursing process. Other key terms are straightforward vocabulary words that may be learned and understood by looking at the prefix or suffix. For example, osteoarthritis and osteoporosis both begin with the prefix osteo, which means “bone.” Learning the meaning of prefixes like osteo will help you decipher other words too. The words agonist and antagonist are similar; both have the word agonist in them. You will want to question how these words are related as well as what difference exists between the two words. Many students find that writing out flash cards helps them to study and learn the key terms. If you choose this method, remember to also include some type of application of the word or phrase. That way, you are not just memorizing but rather making connections to previous learning and relating it to the nursing process. Memorizing is lower-level learning, whereas application is 72 higher-level learning. Some e-books have built-in flash cards of all the vocabulary words, making the process of self-quizzing easy. Just remember that these may not be as in-depth as the flash cards you make yourself. There are also applications that may be downloaded on a computer, smart phone, or tablet that will allow you to bring them up on your device anywhere to study instantly. That way, you can learn at your own pace and at any time. Text Notation Text notation is a way for students to pick out the important content as they are reading the chapters. Many students accomplish this by underlining or highlighting the text as they read. A major mistake is to begin underlining or highlighting the text the first time through. What happens on the first read through is that everything seems important, and before you know it you have marked whole paragraphs as important. The best way to prevent this from occurring is to first read through the material once without underlining or highlighting. You need to see where the author is leading you and what content is being presented in the chapter. Then you need to be aware of the author's language. You can usually tell when a concept is important. Many times, those key terms are part of the content you will need to underline or highlight. While reading the text a second time, you will be able to be more selective in what you underline or highlight. When students highlight in an effective manner, it makes the learning easier because they can just review chunks of content versus studying entire sections. Highlighting is a feature that is included in most online textbooks. Therefore, if you read your textbook in online format, highlighting is very easy. In some e-books, you can choose different highlight colors to mean different things; for example, yellow is important, red needs clarification, and blue is a definition. Some e-books also automatically take your highlighted text and place it into your notes, turning your note taking into a study guide. When using e-books, students have the capability of adding notes 73 as they read along. This will enhance learning and make studying for tests easier. Students can add information that they obtain in the classroom right into the notes in their e-book. Also, students can add a note with a question about the content if there is something that is not clear; later in class, the note can be used as a reminder to ask the instructor for clarification. Enhanced Typeface Throughout your textbook, the authors have used several types of enhanced typeface and color to draw your attention or focus in on something that they feel is important to understand. When key terms first appear in text, they are set in a blue boldface font. This will help you make connections to the definitions you read in the beginning of the chapter with the application of the terms used in the text. In the text, there are also words or phrases in italics; these are words or phrases that are not included in the key terms but are important in their own right. They signal a term or phrase that a student needs to learn to further comprehend the content. The chapter headings are like signs that tell you what is going to be discussed. The authors begin each section with a heading, and these will appear in the same order in every chapter. In this way, students can recognize the general flow of the content. This helps organize the drug information in a consistent manner. You will notice that there are subheadings that also occur in an orderly fashion. Study Time When a student learns a new topic for the first time, the brain looks for a connection to previous learning. If it finds a connection, then learning the content will be easier. To effectively learn a topic like pharmacology, students will have to spend a significant amount of time studying. It is a good idea if students have a set routine and put aside a specific time to study. Many students find that if they review their lecture notes the same day as the class, it helps them to remember the new concepts that were just introduced. You will 74 need to find out what type of study schedule works best for you. You should not wait until just before a test or exam to study what you have been learning. A better plan is to work with the material frequently. This will enhance the connections formed in your brain as you review the material and help it become part of your longterm memory and learning. Learning Styles One of the best ways to study effectively is to understand the way you learn best, otherwise termed learning styles. Everyone has a particular way that they learn best. Many references identify the learning styles as visual, auditory, and kinesthetic, while other sources define up to seven learning styles, with inclusion of verbal (linguistic), logical (mathematical), solitary (intrapersonal), and social (interpersonal). There are several ways for you to find out your learning style(s). Textbooks and reference books are available, but Internet/web-based resources also provide a wealth of information. A few sites that may prove helpful include http://varklearn.com/the-vark-questionnaire/ and www.educationplanner.org/students/self-assessments/learning-stylesquiz.shtml. Self-assessment learning style tests are available on Internet/web-based sites. Here is a brief overview of each of the seven learning styles. The visual (spatial) learning style prefers using pictures, images, and spatial understanding, such as using mind maps and working with pictures instead of words. The aural style learner prefers sound and music, including recordings, rhymes, and mnemonics and setting the learning of information to jingles. Verbal (linguistic) students learn best with both the spoken and written word, including reading of content aloud, recording of and listening to lectures and to themselves, and participating in role playing. The physical (kinesthetic) style learner best comprehends/utilizes information with the use of their hands and through the sense of touch; these learners benefit from the use of physical objects as much as possible, including writing and drawing. Logical (mathematical) learners like to use logical reasoning and a systems approach; they 75 like to find the reason behind the content and create/use lists of key points in their material. Students who fit the social (interpersonal) learning style prefer learning in groups or with other people; if this is your style, try role playing or working in groups as often as you can. The solitary (intrapersonal) style student learns most effectively on his or her own and uses self-study; he or she will align goals with personal beliefs and values (www.edudemic.com/styles-oflearning). Some of these seven learning styles will overlap, and you may find you learn more effectively with use of more than one learning style. There is no right or wrong way to learn. By identifying your learning style, you can enhance the learning of content and get the most out of the learning experience. Use of Applications Technology has come to play an important part in how students learn and study. As discussed previously, there are many applications (or “apps”) available on smart phones and tablets that students may use to learn, study, and manage their time. You will want to start with your textbook and see what types of technology, learning strategies, and ancillary tools are offered as part of your textbook purchase. The student resources for this textbook include interactive review questions and downloadable files of the key points from each chapter to help you study for tests. Additionally, there are several types of practice questions, critical thinking questions, and case studies that are available in this textbook and online. These questions may be used for independent study or in a group situation. If you are a student who embraces technology, use your smart phone or tablet to conduct a search for apps to download and assist you in learning and/or quizzing yourself on various topics within pharmacology. Flash Cards Flash cards are another method of learning about pharmacology and medications. The kinesthetic learner learns best with these strategies. Students can make up their own flash cards, listing important information about a particular drug they need to learn. 76 Some students write out cards and use different colored inks for the information, like green for drug indications and dosage, red for side effects, orange for contraindications, and blue for nursing implications. Students can use a program on their computers to make the flash cards and bring them up on their smart phone to study later. There are also Internet sites and mobile apps that have premade pharmacology flash cards you can use to quiz yourself. When you know how you learn the best, you can use those strategies to make the most of your time learning and studying pharmacology. Remember that your textbook is a great place to start. Review the additional learning resources that are available from the publisher, and then you can seek out any of the other techniques mentioned in this section to help you successfully master your study time. Study Groups Study groups can be a very successful way to learn and study pharmacology. When working with groups, you have the ability and advantage of getting another person's perspective on a topic. Sometimes another student can explain something in a way that makes it easier for you to understand. A group working together can divide a lesson or assignment so that everyone brings something to the table, with everyone learning from one another. First, you need to find a study group that is compatible with your learning needs and availability. You also want to make sure that the students in your group will use the time together to actually study, discuss, and quiz each other on the material and not waste time engaging in social “chit chat.” The majority of the time together needs to focus on the task at hand. If the group you joined does not meet your needs, do not hesitate to leave it and find a different group. When and where students meet for a study group is also important. The environment needs to be conducive to learning for everyone in the group. Many collegiate/academic and public libraries have study rooms that students can use. Often there is a master sign-up sheet found at the front desk of the library. If the school cafeteria has a quiet section, then that may be another 77 possible location for a study group. A beneficial time to plan a study group would be right after or close to the time after the pharmacology lecture. This planning of time would allow everyone to review and discuss new information. If any information is not clearly understood, it may then be cleared up prior to further study. Chat Rooms and Discussion Groups Because we live in such a mobile society and students lead busy lives with school, raising families, and working, finding time for a study group can be difficult. In these instances, using chat rooms and discussion boards are a great alternative to face-to-face group meetings. Some social media sites allow for the formation of chat rooms where students can all log in to discuss their pharmacology content. These chat rooms need to be set up by a student and are usually free of charge. Feedback from other students from other schools can also be achieved in these social media sites. Chat rooms may be accessed from home, making group meetings/activities more convenient. Many colleges and universities already incorporate online learning and learning management systems. The learning management systems go by various names and are usually used by instructors and professors to upload course content, assignments, and grades. These systems usually have the capability to set up discussion boards. The discussion board facilitates group learning by allowing a forum for a student to post a question on a concept or topic that needs clarification and/or reinforcement. Other students can go to the site and post answers, add questions of their own, or share tips on learning (for example, posting a link to a website with useful mnemonics or other learning strategies). Discussion boards can be designed so the whole class participates or set up for small individual groups. Many of these sites are controlled and monitored by the course instructors. Discussion groups can be accessed from anywhere that a student has an Internet connection. Time Management 78 Time management is an extremely important task to master as a nursing student. You are embarking on a profession in which the learning, educational, and clinical preparation are all very intense. Additionally, the course work is heavy, and time seems to always be running out. However, take heart, because many students have preceded you and made it to the other side. Those students will be the first ones to tell you they could not have done it without strict time management, writing out a schedule, and following it. To be successful at time management, you need to start with a tool to keep you on task. One of the most commonly used tools is the school planner or calendar. You will want to get one that has enough space for each day to accommodate all of the information you need to manage. If you are just juggling classes, a small planner will do. However, if you are a parent in charge of school-age kids and/or attending school and working, you will need a planner that easily accommodates all important dates. The best way to be successful is to plan things out. If a pharmacology test falls on the day after your child's school play or after a long work weekend, you will need to see it in advance. The only way to “see it” is to plot it on a planner, often weeks or months at a time. Nothing makes failure inevitable like being unaware of upcoming work, projects, quizzes, tests, and/or exams and being caught unprepared. Students often make their planners as creative and functional as they can by using stickers, different colored inks, and sticky notes, as well as organizing sections of information. Smart phones and tablets may also be used to help students manage their time and stay on task. Mobile devices have timers and/or alarms that students can set so that they are certain to allow time to study or complete an assignment on time. But remember … planners and other scheduling devices need to be used daily and frequently to be effective! When beginning to use a planner, whether on a handwritten calendar or a smart device, start by filling in all deadlines for papers and assignments, as well as test dates. If you have a study group, put those hours down too. Fill in your family's schedule, and your own work schedule. When you have everything plotted, begin to look for conflicts or dates when school deadlines and home or work 79 obligations overlap. Make plans immediately for what you need to do to be successful in your courses. Maybe you need to ask someone else to fill in for you at work. Time management means making difficult decisions, but these decisions will pay off in the long run. Students find that nursing school can be stressful, but preventing conflicts in their schedules before they happen reduces the stress and the feeling of being overwhelmed. When you have your life in the next 10 to 16 weeks laid out before you, it becomes easier to see when you can catch a break and get some down time. It doesn't seem quite so overwhelming when it is spread out. Sure, there may be a few weeks that look like they will be impossible, such as during midterm and final exams, but knowing what to expect puts it all in perspective. Time management really means you are in control. If you do not plan it, it is easy for your time to begin to control you. You can be as detailed or as sketchy in your planner as you need to be, but the important thing is to make it whatever you need to keep your life running as smoothly as possible. If you have to plot every chapter that you need to read, than plot it. If you only need the assignments and test dates recorded, then just record those. Don’t forget to remind yourself of holidays or days off on your planner. You need a break, and your family needs you too. Put the books aside for one day. Plan on it. Practice Questions The practice questions provided in your textbook are one of the best gifts the authors have given to you. These questions allow you a chance to check your understanding of the content, the concepts, and the overall application of pharmacology to nursing. It is best to use them often when you are reading and as you work in your study groups. Do not just save them for when you are studying for a test. The authors have included NCLEX®-style review questions online and at the end of each chapter. They have included critical thinking and prioritization questions as well as case studies in each chapter. There are also questions available for additional practice on the website http://evolve.elsevier.com/Lilley. These are the type of questions you will be expected to answer on the NCLEX® examination for licensure. Make sure you take time to not only 80 understand why the answer is correct but what made the incorrect answers wrong. You want to understand the rationale behind the reasoning. Again, it is all about making connections and really understanding the content. If you do not understand why an answer is correct, talk it out with your peers or question your instructor. Critical thinking is the hallmark of nursing, and, in order for nurses to practice safely, they need to be able to effectively prioritize. The questions on the NCLEX® examination test both of these nursing skills. The questions on this examination are written at a higher level. Many of the test questions will be at the application or analysis level. This means that pure memorization of the concepts will not be useful. You will be expected to apply and analyze your knowledge about the concept. If you want to be successful on your NCLEX® examination, then the more you practice these types of questions, the better you will become. In turn, learning this skill will help you to be successful on your pharmacology examinations in the classroom. An excellent way to study for these types of questions is to work with your study group and ask each other questions that apply or analyze the concepts. Try to write your own questions to quiz the group. Use the chapter objectives and the key points at the end of the chapter to guide you. Remember to ask questions based on the nursing process because those types of questions will help you critically think and actively apply your knowledge. Complete the NCLEX® questions that are provided in your textbook and the online resources. This will provide you with practice answering the application- and analysis-type questions. In addition to the NCLEX® questions available in your textbook and online, there are numerous NCLEX® review resources available for you to use. NCLEX® review books are available, and most have their questions categorized by topic, so you can practice answering questions according to the topic in your pharmacology book. Others have a single section on pharmacology. On your computer, using a search engine like Google can lead to many websites where you can practice answering questions about pharmacology. There 81 are also applications for tablets and smart phones to practice answering pharmacology NCLEX® questions on the go. Although your actual NCLEX® examination is a few years away, it does not hurt to keep practicing. The more you answer these types of questions, the easier they become. Application of Pharmacology and Making Connections As you learn about the different classifications of drugs, pay attention to the information in boxes placed within the text, tables, figures, and case studies in your chapters. You will discover connections between this information, your previous learning experiences, and the courses you are currently taking. including clinical rotations. If you are taking anatomy and physiology (AP) concurrently with nursing pharmacology, you will want to make connections between how the different drugs affect the various body systems. You will discover shared terminology and vocabulary between your AP course and the anatomy, physiology, and pathophysiology review at the beginning of the chapters. Recognizing these commonalities will make learning easier. If you are enrolled in beginning nursing courses concurrently with your pharmacology, you will notice that nursing textbooks mention drug therapy when discussing patient care. For example, in most nursing programs, the respiratory system is one of the first systems you will learn. Students learn how to conduct a thorough respiratory assessment. When learning about abnormal respiratory conditions, various medications will be included in the treatment plan. Looking at Chapter 37, the disorders of asthma, chronic bronchitis, and emphysema are discussed. The chapter then provides the information on the types of medications that are used in the treatment of these disorders. This is the same information you will encounter in your nursing textbooks. Make the connections. In Chapter 37, there is a Case Study box about Bronchodilators and Corticosteroids for Chronic Obstructive Pulmonary Disease. Using this strategy allows you to make the connections 82 between the patient, Ms. B's disease, and her pharmaceutical treatment plan. The questions contained in the scenario allow you to further connect your learning in pharmacology and other nursing courses. Perhaps you cared for a patient in your clinical rotation with COPD. This case study allows you to see the similarities and differences between two patients with the same diagnosis. This is an important connection to make. These examples demonstrate that nursing pharmacology is not meant to be learned in isolation. Looking for these types of connections among your other courses will assist in your learning. Making connections means you are not just memorizing information for your test day but retaining the conceptual relationships for a deeper understanding. When you become aware of medications and their actions in the human body and their indications as treatment for various diseases, you are applying your knowledge. You can take that application a step further and use it to produce concept maps for patient care or use the deeper understanding to assist your learning in other courses. As you move through your nursing education program, it will become evident that what you are reading and studying in pharmacology will show up again and again. Making these connections early in your nursing program will assist you in learning more complex disease processes and the required nursing care. When you finish the nursing pharmacology course, do not sell the book; it will become a great reference for you to use throughout your nursing education program. Studying for Tests Studying for tests or examinations is part of a process. It should never be a cram session. It is best to think in terms of “preparing” for rather than “studying” for a test or examination. If you have been following the learning strategies outlined above, then you have been preparing for the test or examination all along. You have been making connections and forming long-term memory. When you sit down to prepare for a test, your success depends on several things. First, remember you are not cramming. Second, 83 you are not rereading all of the corresponding chapters again. Third, you are not writing new notes to “add” to your learning. All of these activities are counterproductive at this point. They add too much information to your existing files. The information that you need for the test or examination is pushed farther down, and too much extra information causes your memory files to over-expand. Too much new information just before a test makes retrieving what you already know much more difficult. So instead of rereading the entire chapter, find the section in the chapter for which you feel you need clarification and read only that portion. If writing helps you learn, make note cards from your current notes. Extracting new notes from the book introduces too much new information too late. If you have been making flash cards, composing questions, and quizzing each other in your study group, then you should have a lot of information already stored in your brain (files). The other problem with cramming, rereading, and taking new notes is that it increases your anxiety. You begin to doubt your existing knowledge. You find all sorts of information that you feel you suddenly have to know. Anxiety impedes learning and prevents the free flow of memory. When preparing for a test or examination, if you are confident in your understanding of a topic, leave it be and move on to something else. Rereading and reviewing material that you have mastered takes time away from reviewing content that you are not so sure of. It is okay; the other information will still be there when you need it. Put the notes and books away early, and get a good night's sleep. In the morning, leave the book and notes alone unless you absolutely need to look at something. Otherwise, you may have the urge to cram. If your study group likes to meet before the test/examination, decide if that will help or hurt you. If meeting with your group and answering questions confirms that you are ready for the test/examination, then do it. However, if someone mentions a fact you do not know, will that increase your anxiety and cause you to panic and doubt your readiness? If it will, leave the group; be confident that you already know what you need to be successful. If listening to music frees your mind and calms your nerves, do that instead and enter the classroom just before the test/examination so that your peers will not disturb your calm 84 demeanor. Before you take the test/examination, reassure yourself that you know the material and will do well. There is power in positive thinking. Test-Taking Strategies When you take your test or examination, have a system. It is strongly suggested that if you do not have an answer within a few minutes, you skip the question and move on. You do not want to increase your anxiety or waste time, because most instructors will set a specific time frame for completion of the test. When you read a multiple-choice question, make sure you understand exactly what the question is asking. Many students find highlighting or underlining key words in the stem (the question) helps them to quickly decide what it is really asking. If you know that you are looking for an intervention versus a sign or a symptom, it will help you determine which answer to choose. Many students believe the correct answer will be obvious and stand out from the rest, but this is not true, especially when it comes to NCLEX®-style questions for which several answers will seem correct. Your job is to choose the best answer. The answer choices are called distracters. The wrong answers are there to distract you from choosing the correct answer. Good distracters are very similar to the correct answer, and they allow your instructor to determine whether or not you really understand the concept. A strategy to assist in choosing the best answer is to cover all of the answers as you read the question, which forces you to think critically about the question, recall what you know, and then supply an answer. As you reveal the answers, many times the answer you recalled is one of the options. Choose that answer. Then read the remaining answers to be sure you still like yours. Only change your mind if you are 100% sure that another answer is better. Recheck the stem to make sure your choice indeed answers precisely what the question is asking. This technique works well for the student who has difficulty choosing between two answers. When a student sees all the answers at once and two answers sound correct, it is easy for doubt to set in. Thinking about the concept and 85 the answer your memory provides before seeing the choices helps avoid this dilemma. There will be times when recalling information will not help, or when you will have no idea where the question is leading. In this case, look at each answer and then look for clues in the stem. Sometimes reading all of the answers will alert you to what the answer should be by tugging at your memory, or you may notice that one of the answers is totally wrong. You can start eliminating answers that you know are incorrect. If you get down to two answers, you have a 50% chance of being correct, which is better than leaving it blank. So take your best guess. Be aware of look-alike answers. There may be a subtle difference between the two, so read them carefully. It should then be obvious which one is the distracter. Beware of absolutes like “always,” “never,” or “must” because very few things in life are absolute. These can be easily eliminated most of the time. In pharmacology, you will often be tested on the terminology or vocabulary involved. You need to be very careful when choosing answers for these types of questions. Again, watch the spelling. You will notice that many terms are similar in spelling and meaning. To know what the question is asking, you may also have to pay attention to the exact spelling of key terms when you make flash cards. Simple words like hypotension and hypertension may be misread or transposed when you are feeling anxious. If you have difficulty with a question and you truly do not know what it is asking, seek the assistance of your instructor. There is a 50-50 chance he or she can help you. The faculty member might tell you that the query you are posing cannot be answered without giving away the answer or may rephrase the question in a way that makes it easier for you to understand. If you ask what a term means and the vocabulary word is one that you should know, you will most likely not receive any help. Therefore, again, commit your key terms to memory! Many schools now use electronic testing. Be sure to follow the instructions given at the beginning of the exam and “flag” questions if you are allowed to skip questions then return to them later. Be sure to mark your answers carefully. Use the calculator 86 that is provided for dosage calculation questions to avoid making a simple math error. If you are recording your answers on an answer sheet, make sure you write each one correctly. If you skip one row, the whole answer sheet will be off. When you are taking tests and examinations, remain aware of the time so that you will not have to scramble to complete the last few pages. Not all proctors give a warning when time is almost up. Once you have finished, turn in the test. Rereading and reviewing your answers invites the temptation to change answers. Be confident that you did your best. When you receive the results, you can complete a performance evaluation to better understand the outcome. Performance Evaluation After you have taken your test or examination in pharmacology, it is suggested that you conduct a learning self-evaluation. This evaluation needs to be completed whether or not you performed well on the examination and no matter the score. Some appropriate questions include the following: How well did you actually perform on the examination? Which areas did you struggle with? Which types of answers came effortlessly to you? Which questions or content areas did you understand quickly and easily versus a limited or incomplete comprehension? To move forward with successful performances on tests, look at your strengths and weaknesses and apply them to acquire greater understanding of the content. If you are not able to determine the rationale for a poor performance on a test, or if you lack understanding of lectures, readings, and assignments, do not hesitate to speak with your faculty member, who may be able to identify your problematic areas and is equipped to provide advice for identifying and then focusing on the right content. After you have done a thorough selfevaluation, it will be easy to know where you need to change. Reviewing your learning strategies will help ensure your success. Above all, never hesitate to talk with your instructor. It is easier for a faculty member to offer assistance and tutoring to get you back on track early in the term, rather than trying to help when there are 87 only a few points left between you passing and failing the course. Future Application By this point, you are well aware of just how essential the acquisition of pharmacology knowledge is to the profession of nursing. While the administration of medications is a task that anyone can perform with minimal direction, it takes immense knowledge and understanding of pharmacology to administer medications correctly and safely. One of the features of your pharmacology textbook that has not been discussed in your learning strategies is the safety aspect of medication administration. In Chapter 1, the authors explain QSEN and how quality and safe nursing care are extremely important. Nursing programs are being challenged to begin the inclusion of QSEN in their curriculum. It is in the hope that preparing future nurses with the necessary knowledge, skills, and attitudes will enable them to carry those skills into the institutions where they practice and apply them to improve the quality and safety of patient care. Throughout your textbook, you will learn and apply the QSEN competencies. You will read about Evidence-Based Practice. You will see examples of teamwork and collaboration. Patient-centered care is woven throughout your textbook. It cannot be stressed enough how crucial medication safety is to patient care. As you learn more about medications and the characteristics of the different classifications of drugs, it will become apparent that nurses play a vital role in safe medication delivery and the prevention of medication errors. In Chapter 5, you will learn about the impact medication errors have on patients and why the prevention and reporting of errors is crucial. As nurses, you will realize that you are the last checkpoint in the chain of safe administration. You cannot fulfill this role if you do not have a strong understanding of the medications and pharmacotherapeutics. As you study your textbook, pay particular attention to the boxes on patient safety. This information is critical to your current lesson and your future nursing practice. To safely administer medications, always use the Nine Rights of medication administration, and watch for high-alert medications and look- 88 alike, sound-alike drugs. Also, remember to only use approved abbreviations. In Chapter 5, you will also learn how technological advances (with computerized order entry and bar coding for medications), while closing the gap on medication errors, is still not foolproof. Technology is only as good as the people using it, so you must still be very diligent and careful. Learn to live by the mantra, “When in doubt, check it out.” If something does not “feel right,” or if your patient questions a medication, that should be your signal to stop and investigate. Never hesitate to call a pharmacist if something does not sound right. Pharmacists and technicians are human, and they make mistakes. As the final check, nurses can catch a mistake before it reaches the patient. That is why it is imperative that you have a good understanding of pharmacology so that you can easily detect when something is not right. The pharmacology concepts you are learning will reappear in your various nursing courses. The information you learn now will have implications for your future nursing practice, and a certain percentage of pharmacology questions will appear on your NCLEX® examination. New medications are being developed every day. In the future, when you encounter a medication that is brand new or just new to you, you'll want to look it up and learn about it as you do now in your pharmacology course. When you become a nurse, the learning never ends. You never want to be in a situation in which your patient asks you a question about his or her medication and you do not know the answer. One way to stay current with pharmacology is to subscribe to nursing journals. Articles may highlight new drugs, or there may be a news section to convey this information. You can also subscribe to various online resources like Medscape.com, which provides articles and news briefs on pharmacology. The FDA.org website offers a twice-monthly newsletter and e-mail updates on various drug-related topics. Information on medications that have just been approved as well as those on the recall list is also available. Various nursing organizations let their members know about new drugs in their area of expertise. You can have many of these updates sent to you in e-mails; for example, the Oncology Nursing Society sends out email updates on new chemotherapeutic medications to their 89 members. There are various drug applications and drug handbooks available for your smart phone or tablet that you can use in your nursing program and future practice. Drug information is readily available on most health care institution computer systems as well. It is also a good idea to become familiar with the pharmacy department at your institution. The pharmacist can provide a wealth of knowledge to assist you with any questions you have about drug administration, adverse effects, and patient teaching. All the knowledge you are gaining in nursing pharmacology will assist you in providing safe, quality nursing care, and this is only the beginning; you will continue to broaden your horizons in nursing pharmacology with increased understanding and application of your knowledge. 90 PA R T 1 Pharmacology Basics OUTLINE 1 The Nursing Process and Drug Therapy 2 Pharmacologic Principles 3 Lifespan Considerations 4 Cultural, Legal, and Ethical Considerations 5 Medication Errors Preventing and Responding 6 Patient Education and Drug Therapy 7 Over-the-Counter Drugs and Herbal and Dietary Supplements 8 Gene Therapy and Pharmacogenomics 9 Photo Atlas of Drug Administration 91 1 The Nursing Process and Drug Therapy OBJECTIVES When you reach the end of this chapter, you will be able to do the following: 1. List the five phases of the nursing process. 2. Identify the components of the assessment process for patients receiving medications, including collection and analysis of subjective and objective data. 3. Discuss the process of formulating human need statements (previous editions identified nursing diagnoses) for patients receiving medications. 4. Identify the planning phase of the nursing process with outcome identification as related to patients receiving medications. 5. Discuss the evaluation process associated with the administration of medications and as reflected by outcome identification. 6. Develop a nursing care plan that is based on the nursing process and medication administration. 7. Briefly discuss the “Nine Rights” and other “Rights” associated with safe medication administration. 8. Discuss the connection between Quality and Safety Education for Nurses (QSEN) and interprofessional education (IPE) to the 92 improvement of patient outcomes. 9. Discuss the professional responsibility and standards of practice for the professional nurse as related to the medication administration process. KEY TERMS Compliance Implementation or fulfillment of a prescriber's/caregiver's prescribed course of treatment or therapeutic plan by a patient. Use of compliance versus the term adherence acknowledges the consideration/acceptance of patient/family/caregiver participation in the use of the nursing process. Medication error Any preventable adverse drug event involving inappropriate medication use by a patient or health care professional; it may or may not cause the patient harm. Noncompliance An informed decision on the part of the patient not to adhere to or follow a therapeutic plan or suggestion. Nursing process An organizational framework for the practice of nursing. It encompasses all steps taken by the nurse in caring for a patient: assessment, identification of human needs, planning (with goals and outcome criteria), implementation of the plan (with patient teaching), and evaluation. Outcomes Descriptions of specific patient behaviors or responses that demonstrate meeting of or achievement of behaviors related to each patient's human needs. These statements are specific while framed in behavioral terms and are measurable. Prescriber Any health care professional licensed by the appropriate regulatory board to prescribe medications. Overview of the Nursing Process 93 The nursing process is a well-established, research-supported framework for professional nursing practice. The nursing process begins first with an understanding of underlying concepts associated with the art and science of nursing. It is a flexible, adaptable, and adjustable five-step process consisting of assessment, human need statements, planning with outcome identification, implementation including patient education, and evaluation. As such, the nursing process ensures the delivery of thorough, individualized, and quality nursing care to patients, regardless of age, gender, culture, medical diagnosis, or setting. Through use of the nursing process combined with knowledge and skills, the professional nurse will be able to develop effective solutions to meet patient's needs. The nursing process is usually discussed in nursing courses and/or textbooks that deal with the fundamentals of nursing practice, nursing theory, physical assessment, adult or pediatric nursing, and other nursing specialty areas. However, because of the importance of the nursing process and its application in the care of patients, the five phases of the nursing process will be described in each chapter as it relates to specific drug groups or classifications. Critical thinking is a major part of the nursing process and involves the use of thought processes to gather information and then develop conclusions, make decisions, draw inferences, and reflect upon all aspects of patient care. The elements of the nursing process address the physical, emotional, spiritual, sexual, financial, cultural, and cognitive aspects of a patient. Attention to these many aspects allows a more holistic approach to patient care. For example, a cardiologist may focus on cardiac functioning and pathology, a physical therapist on movement, and a chaplain on the spiritual aspects of patient care. However, it is the professional nurse who critically thinks and processes all points of information, incorporates all these data about the patient, and then uses this information to develop and coordinate patient care. Therefore the nursing process remains a central process and framework for nursing care. Box 1.1 provides guidelines for nursing care planning related to drug therapy and the nursing process. 94 Box 1.1 Guidelines for Nursing Care Planning This sample presents useful information for developing a nursing process–focused care plan for patients receiving medications. Brief listings and discussions of what must be contained in each phase of the nursing process are included. This sample may be used as a template for formatting nursing care plans in a variety of patient care situations/settings. Assessment Objective Data Objective data include information available through the senses, such as what is seen, felt, heard, and smelled. Among the sources of data are the medical record, laboratory test results, reports of diagnostic procedures, physical assessment, and examination findings. Examples of specific data are age, height, weight, allergies, medication profile, and health history. Subjective Data Subjective data include all spoken information shared by the patient, such as complaints, problems, or stated needs (e.g., patient complains of “dizziness, headache, vomiting, and feeling hot for 10 days”). Human Need Statements Once the assessment phase has been completed, the nurse analyzes objective and subjective data about the patient and the drug and formulates statements of human need fulfillment/alteration. The following is an example of a human need statement: “Altered safety needs, risk for injury, related to medication-induced sedation as evidenced by decreased sensorium, dizziness, confusion…” This statement of human need can be broken into three parts, as follows: • Part 1—“Altered safety needs, risk for injury” is the statement of the human response of the patient to illness, injury, medications, or significant change. This can be an actual response, an increased risk, or an opportunity to improve the patient's health status. Part 2—“Related to lack of experience 95 with medication regimen and second-grade reading level as an adult.” This portion of the statement identifies factors related to the response; it often includes multiple factors with some degree of connection between them. The human need statement does not necessarily claim that there is a cause-andeffect link between these factors and the response, only that there is a connection. • Part 3—“As evidenced by inability to perform a return demonstration and inability to state adverse effects to report to the prescriber.” This statement lists clues, cues, evidence, and/or data that support the nurse's claim that the human need statement is accurate. Human need statements are prioritized in order of criticality based on patient needs or problems. The ABCs of care (airway, breathing, and circulation) are often used as a basis for prioritization. Prioritizing always begins with the most important, significant, or critical need of the patient. Human need statements that involve actual responses are always ranked above statements that involve only risks. Planning: Outcome Identification The planning phase includes the identification of outcomes that are patient oriented and provide time frames. Outcomes are objective, realistic, and measurable patient-centered statements with time frames. Implementation In the implementation phase, the nurse intervenes on behalf of the patient to address specific patient problems and needs. This is done through independent nursing actions; collaborative activities such as physical therapy, occupational therapy, and music therapy; and implementation of medical orders. Family, significant others, and caregivers assist in carrying out this phase of the nursing care plan. Specific interventions that relate to particular drugs (e.g., giving a particular cardiac drug only after monitoring the patient's pulse and blood pressure), nonpharmacologic interventions that enhance the therapeutic effects of medications, and patient education are 96 major components of the implementation phase. See the previous text discussion of the nursing process for more information on nursing interventions. Evaluation Evaluation is the part of the nursing process that includes monitoring whether patient outcomes, as related to the human need statements, are met. Monitoring includes observing for therapeutic effects of drug treatment, as well as for adverse effects and toxicity. Many indicators are used to monitor these aspects of drug therapy, as well as the results of appropriately related nonpharmacologic interventions. If the outcomes are met, the nursing care plan may or may not be revised to include new human need statements; such changes are made only if appropriate. If outcomes are not met, revisions are made to the entire nursing care plan with further evaluation. Before further discussion of the phases of the nursing process, it is important to mention two contemporary trends in the educational preparation of nurses and other health care professionals. First is the implementation of Quality and Safety Education for Nurses (QSEN) initiatives within the realm of nursing education. The QSEN project, initiated in 2005, was developed to address the continued challenge of preparing future nurses with the knowledge, skills, and attitudes (called KSAs) needed to continuously improve the quality and safety of patient care within the health care system. These KSAs flow out of the QSEN initiatives and are being integrated into nursing education curricula and clinical outcomes. The six major initiatives include the following: patient-centered care, teamwork and collaboration, evidence-based practice (EBP), quality improvement (QI), safety, and informatics. Because of this growing trend for increasing core competencies of quality and safety within nursing education and practice, QSEN-focused boxes as related to drug therapy and the nursing process will be included in several chapters. Second is the development of the Interprofessional Education Collaborative (IPEC). In 2009 IPEC formed with the intent to develop core competencies for interprofessional collaborative practice building 97 upon the disciplinary competencies for the professions of dentistry, medicine, nursing, osteopathic medicine, pharmacy, and public health. As noted by the World Health Organization (2010), interprofessional education occurs when students from two or more professions learn from and with each other with the objective of effective collaboration to improve health outcomes. As the students learn to work within an interprofessional framework, they become prepared to enter the workplace as an important member of the collaborative practice team. These initiatives and behaviors are important to mention because they have been identified as helping health care systems in moving out of fragmentation and into a position of strength. Assessment During the initial assessment phase of the nursing process, data are collected, reviewed, and analyzed from patient, family, group, and/or community sources. Performing a comprehensive assessment allows you to organize the information collected and then place this information into meaningful categories of knowledge known as human need statements. Formulating a human need statement focuses on how the data collected signify a problem, strength, or vulnerability. For the purposes of this textbook, human need statements will be related to drug therapy. Information about the patient may come from a variety of sources, including the patient; the patient's family, caregiver, or significant other; and the patient's medical record. Methods of data collection revolve around interviewing, direct and indirect questioning, observation, medical records review, head-to-toe physical examination, and a nursing assessment. Data are categorized into objective and subjective data. Objective data may be defined as any information gathered through the senses or that which is seen, heard, felt, or smelled. Objective data may also be obtained from a nursing physical assessment; nursing history; past and present medical history; results of laboratory tests, diagnostic studies, or procedures; measurement of vital signs, weight, and height; and medication profile. A medication profile or a medication history review includes, but is not limited to, the following information: allergies of any type; any 98 and all drug use; listing of all prescribed medications; use of home or folk remedies and herbal and/or homeopathic treatments, plant or animal extracts, and dietary supplements; intake of alcohol, tobacco, and caffeine; current or past history of illegal drug use; use of over-the-counter (OTC) medications (e.g., aspirin, acetaminophen, vitamins, laxatives, cold preparations, sinus medications, antacids, acid reducers, antidiarrheals, minerals, elements); use of hormonal drugs (e.g., testosterone, estrogens, progestins, oral contraceptives); past and present health history and associated drug regimen(s); family history and racial, ethnic, and/or cultural attributes, with attention to specific or different responses to medications, as well as any unusual individual responses; growth and developmental stage (e.g., Erikson's developmental tasks) with attention to issues related to the patient's age and medication regimen. A holistic nursing assessment includes the gathering of data about the whole individual, including physical/emotional realms, religious preference, health beliefs, sociocultural characteristics, race, ethnicity, lifestyle, stressors, socioeconomic status, educational level, motor skills, cognitive ability, support systems, and use of any alternative and complementary therapies. Subjective data include information shared through the spoken word by any reliable source, such as the patient, spouse, family member, significant other, and/or caregiver. Assessment about the specific drug is also important and involves the collection of specific information about prescribed, OTC, and herbal/complementary/alternative therapeutic drug use, with attention to the drug's action; signs and symptoms of allergic reaction; adverse effects; dosages and routes of administration; contraindications; drug incompatibilities; drug-drug, drug-food, and drug–laboratory test interactions; and toxicities and available antidotes. Nursing pharmacology textbooks provide a more nursing-specific knowledge base regarding drug therapy as related to the nursing process. Use of current references or those dated within the past 3 years is highly recommended. Some examples of authoritative textbook sources include the Physicians’ Desk Reference, Mosby's Drug Consult, drug manufacturers’ inserts, drug handbooks, and/or licensed pharmacists. Authoritative journal references include professional journals within the past 3 to 5 years 99 that are refereed. Refereed journals are professional journals or publications in which articles/papers are selected for publication by a panel of readers/referees who are experts in the field. Reliable online resources include, but are not limited to, the US Pharmacopeia (USP) (www.usp.org), and the US Food and Drug Administration (FDA) (www.fda.gov). Other online resources are cited throughout this textbook. Gather additional data about the patient and a given drug by asking these simple questions: What is the patient's oral intake? Tolerance of fluids? Swallowing ability for pills, tablets, capsules, and liquids? If there is difficulty swallowing, what is the degree of difficulty and are there solutions to the problem? Use of thickening agents with fluids or use of other dosage forms because of difficulty swallowing? What are the results of laboratory and other diagnostic tests related to organ functioning and drug therapy? What do renal function studies (e.g., blood urea nitrogen level, serum creatinine level) reveal? What are the results of hepatic function tests (e.g., total protein level, serum levels of bilirubin, alkaline phosphatase, creatinine phosphokinase, other liver enzymes)? What are the patient's white blood cell and red blood cell counts? Hemoglobin and hematocrit levels? Current as well as past health status and presence of illness? What are the patient's experiences with use of any drug regimen? What has been the patient's relationship with health care professionals and/or experiences with previous therapeutic regimens? What are current and past values for blood pressure, pulse rate, temperature, and respiratory rate? What medications is the patient currently taking, and how is the patient taking and tolerating them? Are there issues of compliance? Is there any use of folk medicines or folk remedies? What is the patient's understanding of the medication? Are there any agerelated concerns? If patients are not reliable historians, family members, significant others, and/or caregivers may be able to provide answers to these questions. It is worth mentioning that there is often discussion about the difference between the terms compliance and adherence. Both of these terms, although not to be used interchangeably, are used to describe the extent to which patients take medications as prescribed. Often the term adherence is perceived as implying more 100 collaboration and active role between patients and their providers (see Key Terms definition of compliance). Once assessment of the patient and the drug has been completed, the specific prescription or medication order (from any prescriber) must be checked for the following seven elements: (1) patient's name, (2) date the drug order was written, (3) name of drug(s), (4) drug dosage amount, (5) drug dosage frequency, (6) route of administration, and (7) prescriber's signature. It is also important during assessment to consider the traditional, nontraditional, expanded, and collaborative roles of the nurse. Physicians and dentists are no longer the only practitioners legally able to prescribe and write medication orders. Nurse practitioners and physician assistants have gained the professional privilege of legally prescribing medications. Remain current on legal regulations, as well as specific state nurse practice acts and standards of care. Analysis of Data After data about the patient and drug have been collected and reviewed, critically analyze and synthesize the information. Clinical reasoning is the foundation of analyzing data and applying that data to the development of human need statements. Verify all information and document appropriately. It is at this point that the sum of the information about the patient and drug are used in the development of these human need statements. Case Study Patient-Centered Care: The Nursing Process and Pharmacology 101 (© Jose AS Reyes.) Dollie, a 27-year-old social worker, is visiting the clinic today for a physical examination. She states that she and her husband want to “start a family,” but she has not had a physical for several years. She was told when she was 22 years of age that she had “anemia” and was given iron tablets, but Dollie states that she has not taken them for years. She said she “felt better” and did not think she needed them. She denies any use of tobacco and illegal drugs; she states that she may have a drink with dinner once or twice a month. She uses tea tree oil on her face twice a day to reduce acne breakouts. She denies using any other drugs. 1. What other questions does the nurse need to ask during this assessment phase? 2. After laboratory work is performed, Dollie is told that she is slightly anemic. The prescriber recommends that she resume taking iron supplements as well as folic acid. She is willing to try again and says that she is “all about doing what's right to stay healthy and become a mother.” What human need statements would be appropriate at this time? 3. Dollie is given a prescription that reads as follows: “Ferrous sulfate 325 mg, PO for anemia.” When she goes to the pharmacy, the pharmacist tells her that the prescription is incomplete. What is missing? What should be done? 4. After 4 weeks, Dollie's latest laboratory results indicate that she still has anemia. However, Dollie states, “I feel so much better that I'm planning to stop taking the iron tablets. I hate to take pills.” How should the nurse handle this? 102 Identification of Human Need Statements Identification of human needs occurs with the collection of patient data. Human need statements are subsequently developed by professional nurses and are used as a means of communicating and sharing information about the patient and the patient experience. Identification of human needs is the result of clinical judgement about a human response to health conditions and/or life processes, critical thinking, creativity, and accurate collection of data regarding the patient as well as the drug. Human need statements associated with drug therapy develop out of data associated with various disturbances, deficits, excesses, impairments in bodily functions, and/or other problems or concerns as related to drug therapy. See Box 1.2 for a brief listing of human need statements. The development of nursing diagnoses, used in the previous edition, will be replaced with statements consistent with human need theory. Box 1.2 A Brief Listing of Human Needs Autonomous choice Basic physiologic needs: food, fluids and nutrients; elimination (gastrointestinal and urinary); reproductive function; physical activity Belongingness and love Effective perception Esteem need Freedom from pain Interchange of gases Self-actualization needs Self-control Self-determination Self-esteem Spiritual integrity 103 Modified from Petro-Yura, H., & Walsh, M. B. (1983). Human needs 2 and the nursing process. Washington DC: Catholic University of America Press. Formulation of human need statements remains a three-step process as follows: Part 1 of the statement is the human need. Part 2 of this statement addresses further attention to the differences in human need fulfillment or alteration occurring in all individuals regardless of age, gender, educational, cultural, setting and socioeconomic situation (Yura & Walsh, 1978). Statement of the nursing human needs (alteration, fulfillment) does not necessarily claim a cause-and-effect link between these factors and the response; it indicates only that there is a connection between them. Part 3 of the statement of human needs (as with the previous use of nursing diagnoses) contains a listing of clues, cues, evidence, signs, symptoms, or other data that support the nurse's claim that this human need statement is accurate. Tips for writing nursing diagnoses include the following: Begin with a “statement” of a human need; connect the first part of the statement or the human response with the second part, the cause, using the phrase “related to”; be sure that the first two parts are not restatements of one another; include several factors in the second part of the statement, such as associated factors, if appropriate; select a cause for the second part of the statement that can be changed by nursing interventions; avoid negative wording or language; and, finally, list clues or cues and/or more defining characteristics that led to the nursing diagnosis in the third part of the statement or “as evidenced by.” The suggested format to be utilized when formulating a nursing human need statement may look like this: Altered sensory integrity, decreased, related to medication-induced altered level of consciousness as evidenced by sleepiness, decreased reflexes, decreased orientation to place and time. Completing a nursing human need statement is as simple as linking the above three statements! Some of the human needs include the need for nutrition, territoriality, air, to love and to be loved, tenderness, activity, sleep, safety, food, fluids, elimination, and physical safety. See Box 1.2 for a listing of Yura and Walsh's human needs. 104 Planning: Outcome Identification After data are collected and human need statements are formulated, the planning phase begins; this includes identification of outcomes. The major purpose of the planning phase is to prioritize the human needs and specify outcomes including the time frame for their achievement. The planning phase provides time to obtain special equipment for interventions, review the possible procedures or techniques to be used, and gather information for oneself (the nurse) or for the patient. This step leads to the provision of safe care if professional judgment is combined with the acquisition of knowledge about the patient and the medications to be given. In the 1990s the American Nurses Association (ANA) expanded the nursing process to include outcome identification as part of the planning phase. Outcomes are objective, measurable, and realistic with an established time frame for their achievement. Patient outcomes reflect expected and measurable changes in behavior through nursing care and are developed in collaboration with the patient. Patient outcomes are behavior based and may be categorized into physiologic, psychological, spiritual, sexual, cognitive, motor, and/or other domains. They are patient focused, succinct, and well thought out. Outcomes also include expectations for behavior, indicating something that can be changed and with a specific time frame or deadline. The ultimate aim of outcome identification, pertinent to drug therapy, is the safe and effective administration of medications. Outcomes need to reflect each human need statement and serve as a guide to the implementation phase of the nursing process. Formulation of outcomes begins with the analysis of the judgments made about patient data and subsequent human need(s) statement and ends with the development of a nursing care plan. They also provide a standard for measuring movement toward goals. With regard to medication administration, these outcomes may address special storage and handling techniques, administration procedures, equipment needed, drug interactions, adverse effects, and contraindications. In this textbook, specific time frames are not provided in each chapter's nursing process section because patient care is individualized in each patient care situation. 105 Implementation Implementation is guided by the preceding phases of the nursing process (i.e., assessment, statement of human needs, and planning). Implementation requires constant communication and collaboration with the patient and with members of the health care team involved in the patient's care, as well as with any family members, significant others, or other caregivers. Implementation consists of initiation and completion of specific nursing actions as defined by the statement of human needs and outcome identification. Implementation of nursing actions may be independent, collaborative, or dependent upon a prescriber's order. Interventions are defined as any treatment based on clinical judgment and knowledge and performed by a nurse to enhance outcomes. Statements of interventions include frequency, specific instructions, and any other relevant information. With medication administration, you need to know and understand all of the information about the patient and about each medication prescribed. In years past, nurses adhered to the “Five Rights” of medication administration: right drug, right dose, right time, right route, and right patient. However, this edition strongly encourages the use of the “Nine Rights” of medication administration inclusive of the basic “Six Rights.” The Nine Rights are discussed in the following section. These “rights” of medication administration have been identified as additional standards of care as related to drug therapy. Even implementation of these “rights” does not reflect the complexity of the role of the professional nurse because they focus more on the individual/patient than on the system as a whole or the entire medication administration process beginning with the prescriber's order. Nine Rights of Medication Administration Right Drug The “right drug” begins with the registered nurse's valid license to practice. Most states allow currently licensed practical nurses to administer medications with specific guidelines. The registered nurse is responsible for checking all medication orders and/or 106 prescriptions. To ensure that the correct drug is given, the specific medication order must be checked against the medication label or profile three times before giving the medication. Conduct the first check of the right drug/drug name during your initial preparation of the medication for administration. At this time, consider whether the drug is appropriate for the patient and, if doubt exists or an error is deemed possible, contact the prescriber immediately to verify the drug order. It is also appropriate at this time to note the drug's indication and be aware that a drug may have multiple indications, including off-label use and non–FDA-approved indications. In this textbook, each particular drug is discussed in a specific chapter that deals with its main indication, but the drug may also be cross-referenced in other chapters if it has multiple uses. All medication orders or prescriptions are required by law to be signed by the prescriber involved in the patient's care. If a verbal order is given, the prescriber must sign the order within 24 hours or as per guidelines within a health care setting. Verbal and/or telephone orders are often used in emergencies and time-sensitive patient care situations. To be sure that the right drug is given, information about the patient and drug (see previous discussion of the assessment phase) must be obtained to make certain that all variables and data have been considered. See previous discussion about authoritative sources/references. Avoid relying upon the knowledge of peers because this is unsafe nursing practice. Remain current in your knowledge of generic (nonproprietary) drug names, as well as trade names (proprietary name that is registered by a specific drug manufacturer); however, use of the drug's generic name is now preferred in clinical practice to reduce the risk for medication errors. A single drug often has numerous trade names, and drugs in different classes may have similarly spelled names, increasing the possibility of medication errors. Therefore, when it comes to the “right drug” phase of the medication administration process, use of a drug's generic name is recommended to help avoid a medication error and enhance patient safety. (See Chapter 2 for more information on the naming of drugs.) 107 Evidence-Based Practice Nurses’ Clinical Reasoning: Processes and Practices of Medication Safety Review In one of the first quality reports about medication safety in the series To Err Is Human (2000), Kohn, Corrigan, and Donaldson identified medication errors as the most common of errors occurring in health care. In 2007 in another quality series, Aspden and colleagues reported that a patient in a hospital could expect at least one medication error per hospital day. They also reported that as many as 7000 deaths might occur in hospitals each year because of medication errors, with a great variation among hospitals as to the number of events reported. It is important to note that in 1994 (Leape), research on medication errors changed from one of individual focus to one of a series of failures or breakdowns in the complexity of health care systems. Lacking in most of the medication error research is the critical role that professional nurses play in preventing medication errors from reaching the patient. Not only did a process need to be researched but especially the phenomenon behind the process of prevention of errors, which led to this particular qualitative research study. This study was designed to look at the nurse's clinical reasoning and actions preventing the medication error prior to even reaching the patient. Methodology Grounded theory was used to identify the essence of medication safety. This qualitative method research design was used in an attempt to understand the world of preventing medication errors by the nurse and to gain an understanding of their knowledge. Qualitative research is a method of inquiry used in social and natural sciences as well as in nonacademic contexts such as market research. It is a broad methodology used to often examine the how and why of decision making and not just the who, what, where, and when. This type of research is important to use in the context of exploring study participants within their environment … 108 looking at understanding human behavior and reasons for that behavior … the why and how of decision-making versus the empirical investigation through statistical analysis. Nurses were interviewed face-to-face about what they thought and did to prevent errors. In addition, they were asked to identify factors that they thought increased the likelihood of a medication error occurring and how they made a difference in the interception of errors. A purposive sample of 50 medical-surgical nurses from 10 mid-Atlantic hospitals was used. Interviews, conducted in private settings on hospital units, included open-ended questions regarding their processes, and taped recordings were approximately 60 minutes in length. Findings The analysis of data was one of the discovery (of grounded theory) beginning with a line-by-line analysis of the narratives, with coding of data reflecting the nurses’ thoughts and actions when they recognized something was wrong with the medication and/or patient. An iterative (repetitive) process was used until all categories appeared to be saturated and theoretically sound. Emerging ideas were also categorized during the interviews, and the nurses’ dialogues, researcher observations, and analytic memos provided the data for analysis. The analysis of data revealed that nurses, to ensure patient safety, needed to interact with others. A majority of the nurses clearly acknowledged their role in the process of “Five Rights” of medication administration, as well as the need to extend safe practice beyond these five tasks. Two safety processes were found within the clinical reasoning: The first process was maintaining medication safety with various medication practices, including advocacy with pharmacy, educating patients, and conducting medication reconciliation. The second process was managing the clinical environment with four environmentally focused safety categories, including coping with interruptions and documenting “near misses.” These processes and practices demonstrated nurses’ clinical reasoning that served as a foundation of the “safety net” protecting patients from medication errors. Out of all these narratives, there also emerged a model for the processes and practices of safe medication administration. 109 Application to Nursing Practice Nurses in this study clearly demonstrated how clinical reasoning was used to prevent potential medication errors from reaching the patient. This evidence is critical to further development of medication safety practices for implementation by professional nurses. All processes, practices, and reasoning related to safe medication administration demonstrated by nurses need to be acknowledged, valued, and respected by nurse/health care managers/leaders within the various health care settings. In addition, more research is needed on development of models for safe medication practice that reaches further than just the “Five Rights” and emphasis on astute clinical reasoning. Systemic policies for safer medication administration may be developed out of these practice models. Results of this study may also be helpful in development of nursing curricula focused on patient safety as the very basis of quality patient care. From Dickson, G. L., & Flynn, L. (2012). Nurses’ clinical reasoning: processes and practices of medication safety. Qualitative Health Research, 22(1), 3–16. If there are questions about the medication order at any time during the medication administration process, contact the prescriber for clarification. Never make any assumptions when it comes to drug administration, and, as previously emphasized in this chapter, confirm at least three times the right drug, right dose, right time, right route, right patient, and right documentation before giving the medication. Right Dose Whenever a medication is ordered, a dosage is identified from the prescriber's order. Always confirm that the dosage amount is appropriate for the patient's age and size. Use of a current, authoritative drug reference is encouraged. In addition, check the prescribed dose against the available drug stocks and against the normal dosage range. Recheck all mathematical calculations, and pay careful attention to decimal points, the misplacement of which could lead to a tenfold or even greater overdose. Leading zeros, or 110 zeros placed before a decimal point, are allowed, but trailing zeros, or zeros following the decimal point, are to be avoided. For example, 0.2 mg is allowed, but 2.0 mg is not acceptable, because it could easily be mistaken for 20 mg, especially with unclear penmanship. Patient variables (e.g., vital signs, age, gender, weight, height) require careful assessment because of the need for dosage adjustments in response to specific parameters. Pediatric and elderly patients are more sensitive to medications than are younger and middle-age adult patients; thus use extra caution with drug dosage amounts for these patients. Safety and Quality Improvement: Preventing Medication Errors Right Dose? The nurse is reviewing the orders for a newly admitted patient. One order reads: “Tylenol, 2 tablets PO, every 4 hours as needed for pain or fever.” The pharmacist calls to clarify this order, saying, “The dose is not clear.” What does the pharmacist mean by this? The order says “2 tablets.” Isn't that the dose? NO! If you look up the dosage information for Tylenol (acetaminophen), you will see that Tylenol tablets are available in strengths of both 325 mg and 500 mg. The order is missing the “right dose” and needs to be clarified. Never assume the dose of a medication order! Right Time Each health care setting or institution has a policy regarding routine medication administration times. These policies need to be checked and committed to memory! Include in your three checks the frequency of the ordered medication, the time to be administered, and when the last dose of medication was given. However, when giving a medication at the prescribed time, you may be confronted with a conflict between the timing suggested by the prescriber and specific pharmacokinetic or pharmacodynamic drug properties, 111 concurrent drug therapy, dietary influences, laboratory and/or diagnostic testing, and specific patient variables. For example, the prescribed right time for administration of antihypertensive drugs may be four times a day, but for an active, professional 42-year-old male patient working 14 hours a day, taking a medication four times daily may not be feasible, and this regimen may lead to noncompliance and subsequent complications. For patient safety, your appropriate actions would include contacting the prescriber and inquiring about the possibility of prescribing another drug with a different dosing frequency (e.g., once or twice daily). For routine medication orders, the standard of care is to give the medications no more than hour before or after the actual time specified in the prescriber's order (e.g., if a medication is ordered to be given at 0900 every morning, you may give it at any time between 0830 and 0930); the exception includes medications designated to be given stat (immediately) that must be administered within hour of the time the order is written. Assess and follow the health care institution policy and procedure for any other specific information concerning the “ hour before or after” rule. For medication orders with the annotation “prn” (pro re nata, or “as required”), the medication must be given at special times and under certain circumstances. For example, an analgesic is ordered every 4 to 6 hours prn for pain; after one dose of the medication, the patient complains of pain. After assessment, intervention with another dose of analgesic would occur, but only 4 to 6 hours after the previous dose. In addition, because of the increasing incidence of medication errors related to the use of abbreviations, many prescribers are using the wording “as required” or “as needed” instead of the abbreviation “prn.” Military time is used when medication and other orders are written into a patient's medical record (Table 1.1). TABLE 1.1 Conversion of Standard Time to Military Time Standard Time 1 AM 2 AM Military Time 0100 0200 112 3 AM 4 AM 5 AM 6 AM 7 AM 8 AM 9 AM 10 AM 11 AM 12 PM (noon) 1 PM 2 PM 3 PM 4 PM 5 PM 6 PM 7 PM 8 PM 9 PM 10 PM 11 PM 12 AM (midnight) 0300 0400 0500 0600 0700 0800 0900 1000 1100 1200 1300 1400 1500 1600 1700 1800 1900 2000 2100 2200 2300 2400 Nursing judgment may lead to some variations in timing; however, any change with the rationale for change must be documented and the prescriber contacted. If medications are ordered to be given once every day, twice daily, three times daily, or even four times daily, the times of administration may be changed if it is not harmful to the patient or if the medication or the patient's condition does not require adherence to an exact schedule. For example, suppose that an antacid is ordered to be given three times daily at 0900, 1300, and 1700 but the nurse has misread the order and gives the first dose at 1100. Depending on the specific policy of a hospital or other health care setting, the medication, and the patient's condition, such an occurrence may not be considered an error, because the dosing may be changed once the prescriber is contacted, so that the drug is given at 1100, 1500, and 1900 without harm to the patient and without incident to the nurse. If this were an antihypertensive medication, the patient's condition and physical well-being could be greatly compromised by one missed or late dose. Thus falling behind in dosing times is not to be taken lightly or ignored. Never underestimate the effect of a change in the 113 dosing or timing of medication, because one missed dose of certain medications can be life threatening. Other factors must be considered in determining the right time, such as multiple-drug therapy, drug-drug or drug-food compatibility, scheduling of diagnostic studies, bioavailability of the drug (e.g., the need for consistent timing of doses around the clock to maintain blood levels), drug actions, and any biorhythm effects such as occur with steroids. It is also critical to patient safety to avoid using abbreviations for any component of a drug order (i.e., dose, time, route). Spell out all terms (e.g., three times daily instead of tid) in their entirety. Be careful to write out all words and abbreviations, because the possibility of miscommunication or misinterpretation poses a risk to the patient. The Joint Commission created a “do not use” list of abbreviations in 2010 and integrated the list into their Information Management standards. For accredited facilities, abbreviations are not to be used in internal communications, telephone/verbal prescriptions, computergenerated labels, labels for drug storage bins, medication administration records, and pharmacy and prescriber computer entry screens. Further discussion is included in Chapter 5. Right Route and Form As previously stated, you must know the particulars about each medication before administering it to ensure that the right drug, dose, route, and dosage form are being used. A complete medication order includes the route of administration. Confirm the appropriateness of the prescribed route while also making sure the patient can take/receive the medication by the prescribed route. If a medication order does not include the route, be sure to ask the prescriber to clarify it. Never assume the route of administration. In addition, it is critical to patient safety to be aware of the right form of medication. For example, there are various dosage forms of a commonly used medication, acetaminophen. It is available in oral suspension, tablet, capsule, gelcap, and pediatric drops, as well as rectal suppository dosage forms. Nurses need to give the right drug via the right route with use of the correct dosage form. Another example is the administration of a controlled-release dosage form of a medication. This dosage form is not to be crushed or altered due 114 to the subsequent and immediate release of the drug (versus the controlled release) which, in some cases, may be life threatening. Right Patient Checking the patient's identity before giving each medication dose is critical to the patient's safety. Confirm the name on the order and the patient, and be sure to use several identifiers. Ask the patient to state his or her name, and then check the patient's identification band to confirm the patient's name, identification number, age, and allergies. With pediatric patients, the parents and/or legal guardians are often the ones who identify the patient for the purpose of administration of prescribed medications. With newborns and in labor and delivery situations, the mother and baby have identification bracelets with matching numbers, which must be thoroughly and repetitively checked before giving medications. In older adult patients or those with altered sensorium or level of consciousness, asking the patient his or her name or having the patient state his or her name is neither realistic nor safe. Therefore checking the identification band against the medication profile, medication order, or other treatment or service orders is crucial to avoid errors. When available, use technology such as scanning a bar code on the patient's identification band. In 2016, the Joint Commission published an update to the 2008 National Patient Safety Goals for patient care. These goals emphasize the use of two identifiers when providing care, treatment, or services to patients. To meet these goals, The Joint Commission recommends that the patient be identified “reliably” and also that the service or treatment (e.g., medication administration) be matched to that individual. The Joint Commission's statement of National Patient Safety Goals indicates that the two identifiers may be in the same location, such as on a wristband. In fact, it is patient-specific information that is the identifier. Acceptable identifiers include the patient's name, date of birth, home address, Social Security number, or a hospital/health care facility-assigned identification number. Right Documentation Documentation of information related to medication administration is crucial to patient safety. Recording patient observations and 115 nursing actions has always been an important ethical responsibility, but now it is becoming a major medical-legal consideration as well. Because of its significance in professional nursing practice, correct documentation became known as the “sixth right” of medication administration, adding to the previous use of “Five Rights.” Always assess the prescribed order in the patient's medical record for the presence of the following information: date and time of medication administration, name of medication, dose, route, and site of administration. Document administration only after the medication has been given including the time, route, and any laboratory values or vital signs (as appropriate). Documentation of drug action may also be made in the regularly scheduled assessments for changes in symptoms the patient is experiencing, adverse effects, toxicity, and any other drug-related physical and/or psychological symptoms. Documentation must also reflect any improvement in the patient's condition, symptoms, or disease process, as well as no change or a lack of improvement. You must not only document these observations, but also report them to the prescriber promptly in keeping with your critical thinking and judgment. Document any teaching, as well as an assessment of the degree of understanding exhibited by the patient. Other areas of information that need to be documented include the following: (1) if a drug is not administered, with the reason why and any actions taken (e.g., contacting the prescriber and monitoring the patient), (2) actual time of drug administration, and (3) data regarding clinical observations and treatment of the patient if a medication error has occurred. If there is a medication error, complete an incident report with the entire event, surrounding circumstances, therapeutic response, adverse effects, and notification of the prescriber described in detail. However, do not record completion of an incident report in the medical record. Right Reason or Indication Right reason or indication addresses the appropriateness in use of the medication to the patient. Confirm the rationale for use through researching the patient's history while also asking the patient the reason he or she is taking the drug. Always revisit the rationale for long-term medication use. Knowledge of the drug's indication 116 allows the nurse, prescriber, members of the health care team, patient and/or family members to understand what is being treated. Understanding the indication helps pharmacists and nurses to catch potential errors, provide thorough explanations to the patient/family, and decrease challenges to medication reconciliation. Right Response Right response refers to the drug and its desired response in the patient. Continually assess and evaluate the achievement of the desired response, as well as any undesired response. Examples of data gathering include, but are not limited to, monitoring vital signs, weight, edema, intake and output, nutritional intake, laboratory values, results of diagnostic testing, and auscultating heart and lung sounds. Document any assessment, intervention, and monitoring as deemed appropriate. Right to Refuse The ninth right is that of the right of the patient to refuse. Patients refuse medications for a variety of reasons. If refusal of a medication occurs, always respect the patient's right (to refuse), determine the reason, and take appropriate action, including notifying the prescriber. Do not force! Document the refusal and a concise description of the reason for refusal. Document any further actions you take at this time, such as vital signs and/or system assessment. If a consequence to the patient's condition and/or as hospital policy dictates, the prescriber is to be contacted immediately. Never return unwrapped medication to a container, and discard medication dose according to agency policy. If the wrapper remains intact, return the medication to the automated medication-dispensing system. Revise the nursing care plan as needed. This list is never ending and ever changing, and additional rights to be considered when administering medications include the following: • Patient safety, ensured by use of the correct 117 procedures, equipment, and techniques of medication administration and documentation • Individualized, holistic, accurate, and complete patient education with appropriate instructions • Double-checking and constant analysis of the system (i.e., the process of drug administration including all personnel involved, such as the prescriber, the nurse, the nursing unit, and the pharmacy department, as well as patient education) • Proper drug storage • Accurate calculation and preparation of the dose of medication and proper use of all types of medication delivery systems • Careful checking of the transcription of medication orders • Accurate use of the various routes of administration and awareness of the specific implications of their use • Close consideration of special situations (e.g., patient difficulty in swallowing, use of a nasogastric tube, unconsciousness of the patient, advanced patient age) • Implementation of all appropriate measures to prevent and report medication errors, and the use of nonexpired medications Medication Errors When the Nine Rights (and other rights) of drug administration are discussed, medication errors must be considered. Medication errors are a major problem for all of health care, regardless of the setting. 118 The National Coordinating Council for Medication Error Reporting and Prevention defines a medication error as any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer. Such events may be related to professional practice, health care products, procedures, or systems, including prescribing; order communication; product labeling, packaging, and nomenclature; compounding; dispensing; distribution; administration; education; monitoring; and use (www.nccmerp.org/about-medication-errors). Both patient-related and system-related factors must always be considered when examining the medication administration process and the prevention of medication errors. See Chapter 5 for further discussion of medication errors and their prevention. Evaluation Evaluation occurs after the nursing care plan has been implemented but also needs to occur at each phase of the nursing process. It is systematic, ongoing, and a dynamic phase of the nursing process as related to drug therapy. It includes monitoring the fulfillment of outcomes, as well as monitoring the patient's therapeutic response to the drug and its adverse effects and toxic effects. Documentation is also a very important component of evaluation and consists of clear, concise, abbreviation-free documentation that records information related to goals and outcome criteria, as well as information related to any aspect of the medication administration process, including therapeutic effects versus adverse effects or toxic effects of medications (see Teamwork and Collaboration: Legal and Ethical Principles box). Evaluation also includes monitoring the implementation of standards of care. Several standards are in place to help in the evaluation of outcomes of care, such as those established by state nurse practice acts and by The Joint Commission. Guidelines for nursing services policies and procedures are established by The Joint Commission. There are even specific standards regarding medication administration to protect both the patient and the nurse. The ANA Code of Ethics and Patient Rights statement are also used 119 in establishing and evaluating standards of care. Teamwork and Collaboration: Legal and Ethical Principles Do's and Don'ts of Documentation Do's • Do check to be sure you have the correct medical record before documenting. • Do include the time you gave a medication, the route of administration, and the patient's response. • Do document: • Only the facts • Patient teaching • Any precautions and/or preventative measures • The exact time, message, response when communicating with a physician and/or health care provider • A patient's refusal to take a medication or allow a treatment and appropriate nursing interventions and report to the patient’s physician and the charge nurse. • Do record each phone call to a physician with exact time, message, and response. • Do give precise descriptions. • Do document patient care at the time you provide it. Don'ts • Don't document a symptom, such as “c/o pain,” without noting what you did to intervene on the patient's behalf. • Don't alter a patient's medical record and/or nursing notes. • Don't give excuses, such as “medication not given because not available.” 120 • Don't document ahead of time. • Don't mention the term incident report in documentation. Incident reports are confidential and filed separately. Document only the facts of the medication error or incident and appropriate actions taken. • Don't use the following terms: by mistake, by accident, accidentally, unintentional, or miscalculated. • Don't record casual conversations with peers, prescribers, or other members of the health care team. • Don't use abbreviations. Some agencies or facilities may still keep a list of approved abbreviations, but overall their use is discouraged. • Don't use negative language. Modified from Do's and don'ts of documentation. (2013). Nurses Service Organization. Available at www.nso.com. Accessed March 27, 2015. Guidelines for nursing services policies and procedures are established by The Joint Commission. There are even specific standards regarding medication administration to protect both the patient and the nurse. The ANA Code of Ethics and Patient Rights statement are also used in establishing and evaluating standards of care. In summary, the nursing process is an ongoing and constantly evolving process (see Box 1.1). The nursing process, as it relates to drug therapy, involves the way in which a nurse gathers, analyzes, organizes, provides, and acts upon data about the patient within the context of prudent nursing care and standards of care. The nurse's ability to make astute assessments, formulate human need statements, identify outcomes, implement safe and accurate drug administration, and continually evaluate patients’ responses to drugs increases with additional experience and knowledge. Key Points • The nursing process is an ongoing, constantly 121 changing, and evolving framework for professional nursing practice. It may be applied to all facets of nursing care, including medication administration. • The five phases of the nursing process include assessment; development of human need statements; planning with outcome identification; implementation, including patient education; and evaluation. • Human need statements are formulated based on objective and subjective data and help to drive the nursing care plan. Statements of human needs are then developed and constantly updated and revised. Safe, therapeutic, and effective medication administration is a major responsibility of professional nurses as they apply the nursing process to the care of their patients. • Two contemporary trends in the educational preparation of nurses and other health care professionals include the implementation of Quality and Safety Education for Nurses (QSEN) initiatives in nursing education and the development of Interprofessional Education Collaborative (IPEC). Both trends are aimed at improving the education of nurses and of health care professionals, with the common goal of improving patient care outcomes. • Nurses are responsible for safe and prudent decision-making in the nursing care of their patients, including the provision of drug therapy; 122 in accomplishing this task, they attend to the Nine Rights and adhere to legal and ethical standards related to medication administration and documentation. There are additional rights related to drug administration. These rights deserve worthy consideration before initiation of the medication administration process. Observance of all of these rights enhances patient safety and helps avoid medication errors. Critical Thinking Exercises 1. When medications were administered during the night shift, a patient refused to take his 0200 dose of an antibiotic, claiming that he had just taken it. What is the best action by the nurse to maintain patient safety? 2. During a busy shift, the nurse notes that the medical record of a newly admitted patient has a few orders for various medications and diagnostic tests that were taken by telephone by another nurse. The nurse is on the way to the patient's room to do an assessment when the unit secretary tells the nurse that one of the orders reads as follows: “Lasix, 20 mg, stat.” What is the priority action by the nurse? How does the nurse go about giving this drug? Explain the best action to take in this situation. Review Questions 1. An 86-year-old patient is being discharged to home on drug therapy for hyperthyroidism and has very little information regarding the medication. Which statement best reflects a realistic outcome of patient teaching 123 activities? a. The patient and patient's daughter will state the proper way to take the drug. b. The nurse will provide teaching about the drug's adverse effects. c. The patient will state all the symptoms of toxicity of the drug. d. The patient will call the prescriber if adverse effects occur. 2. A patient has a new prescription for a blood pressure medication that may cause him to feel dizzy during the first few days of therapy. Which is the best human needs statement for this situation? a. Physical activity b. Physical safety c. Freedom pain d. Interchange of gases 3. A patient's medical record includes an order that reads as follows: “Atenolol 25 mg once daily at 0900.” Which action by the nurse is correct? a. The nurse does not give the drug. b. The nurse gives the drug orally. c. The nurse gives the drug intravenously. d. The nurse contacts the prescriber to clarify the dosage route. 4. The nurse is compiling a drug history for a patient. Which questions from the nurse will obtain the most information from the patient? (Select all that apply.) a. “Do you use sleeping pills to get to sleep?” b. “Do you have a family history of heart disease?” 124 c. “When you have pain, what do you do to relieve it?” d. “Did you have the mumps as a child?” e. “Tell me about what happened when you had the allergic reaction to penicillin.” f. “What herbal products or over-the-counter medications do you use?” 5. A 77-year-old man who has been diagnosed with an upper respiratory tract infection tells the nurse that he is allergic to penicillin. Which is the most appropriate response by the nurse? a. “Many people are allergic to penicillin.” b. “This allergy is not of major concern because the drug is given so often.” c. “What type of reaction did you have when you took penicillin?” d. “Drug allergies don't usually occur in older individuals due to built-up resistance to allergic reactions.” 6. The nurse is preparing a care plan for a patient who has been newly diagnosed with type 2 diabetes mellitus. Which of these reflect the correct order of the steps of the nursing process? a. Assessment, planning, human needs statement, implementation, evaluation b. Evaluation, assessment, human needs statement, planning, implementation c. Human needs statement, assessment, planning, implementation, evaluation d. Assessment, human needs statement, planning, implementation, evaluation 125 7. The nurse is reviewing new medication orders that have been written for a newly admitted patient. The nurse will need to clarify which orders? (Select all that apply.) a. metformin (Glucophage) 1000 mg PO twice a day b. sitagliptin (Januvia) 50 mg daily c. simvastatin (Zocor) 20 mg PO every evening d. irbesartan (Avapro) 300 mg PO once a day e. docusate (Colace) as needed for constipation 8. The nurse is reviewing data collected from a medication history. Which of these data are considered objective data? (Select all that apply.) a. White blood cell count 22,000 mm3 b. Blood pressure 150/94 mm Hg c. Patient rates pain as an “8” on a 10-point scale d. Patient's wife reports that the patient has been very sleepy during the day e. Patient's weight is 68 kg References Agency for Healthcare Research and Quality. Quality and patient safety. [March; Rockville, MD; Available at] www.ahrq/professionals/qualitypatientsafety/index.html 2016. Bradley D, Benedict B. The ANA professional nursing development scope and standards, 2009: a continuing education perspective. 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Interprofessional Education Collaborative. Connecting health professions for better care. IPEC News & Announcements. [July 11; Available at] https://ipecollaborative.org/IPEC.html; 2016. The Joint Commission. Facts about the official “Do not use list of abbreviations. [Available at] www.jointcommission.org/fact_about_do_not_use_list 2015. Laysa SM, Fabian RJ, Saul MI, et al. Influence of medications and diagnoses on fall risk in psychiatric inpatients. American Journal of HealthSystem Pharmacy. 2010;67(15):1274–1280. Moorhead SL, Mass ML, et al. Nursing outcomes classification (NOC). 5th ed. Mosby: St Louis, MO; 2013. Mosby. Mosby's dictionary of medicine, nursing and 127 health professions. 10th ed. Mosby: St. Louis; 2017. National Institutes of Health. Falls and older adults. NIH senior health. [Available at] http://nihseniorhealth.gov/falls/causesandriskfactors/ol.html 2013. Petro-Yura H, Walsh MB. Human needs and the nursing process. Catholic University of America Press: Washington DC; 1978. Petro-Yura H, Walsh MB. Human needs 2 and the nursing process. Catholic University of America Press: Washington DC; 1983. Petro-Yura H, Walsh MB. Human needs 3 and the nursing process. Catholic University of America Press: Washington DC; 1983. Trossman S. Better prepared workforce, better retention. [August 17; The American Nurse; Available at] www.theamericannurse.org/2013/09/03/betterprepared-workforce-better-retention/; 2016. World Health Organization (WHO). Framework for action on interprofessional education & collaborative practice. [July 11; Available at] https://ipecollaborative.org/IPEC.html; 2016. 128 2 Pharmacologic Principles OBJECTIVES When you reach the end of this chapter, you will be able to do the following: 1. Define the common terms used in pharmacology (see Key Terms). 2. Understand the general concepts such as pharmaceutics, pharmacokinetics, and pharmacodynamics, and their application in drug therapy and the nursing process. 3. Demonstrate an understanding of the various drug dosage forms as related to drug therapy and the nursing process. 4. Discuss the relevance of the four aspects of pharmacokinetics (absorption, distribution, metabolism, excretion) to professional nursing practice as related to drug therapy for a variety of patients and health care settings. 5. Discuss the use of natural drug sources in the development of new drugs. 6. Develop a nursing care plan that takes into account general pharmacologic principles, specifically pharmacokinetic principles, as they relate to the nursing process. 129 KEY TERMS Additive effects Drug interactions in which the effect of a combination of two or more drugs with similar actions is equivalent to the sum of the individual effects of the same drugs given alone. For example, 1 + 1 = 2 (compare with synergistic effects). Adverse drug event Any undesirable occurrence related to administering or failing to administer a prescribed medication. Adverse drug reaction Any unexpected, unintended, undesired, or excessive response to a medication given at therapeutic dosages (as opposed to overdose). Adverse effects A general term for any undesirable effects that are a direct response to one or more drugs. Agonist A drug that binds to and stimulates the activity of one or more receptors in the body. Allergic reaction An immunologic hypersensitivity reaction resulting from the unusual sensitivity of a patient to a particular medication; a type of adverse drug event. Antagonist A drug that binds to and inhibits the activity of one or more receptors in the body. Antagonists are also called inhibitors. Antagonistic effects Drug interactions in which the effect of a combination of two or more drugs is less than the sum of the individual effects of the same drugs given alone (1 + 1 equals less than 2); it is usually caused by an antagonizing (blocking or reducing) effect of one drug on another. Bioavailability A measure of the extent of drug absorption for a given drug and route (from 0% to 100%). Biotransformation One or more biochemical reactions involving a parent drug; occurs mainly in the liver and produces a metabolite that is either inactive or active. Also known as metabolism. 130 Blood-brain barrier The barrier system that restricts the passage of various chemicals and microscopic entities (e.g., bacteria, viruses) between the bloodstream and the central nervous system. It still allows for the passage of essential substances such as oxygen. Chemical name The name that describes the chemical composition and molecular structure of a drug. Contraindication Any condition, especially one related to a disease state or patient characteristic, including current or recent drug therapy, which renders a particular form of treatment improper or undesirable. Cytochrome P-450 The general name for a large class of enzymes that plays a significant role in drug metabolism and drug interactions. Dependence A state in which there is a compulsive or chronic need, as for a drug. Dissolution The process by which solid forms of drugs disintegrate in the gastrointestinal tract and become soluble before being absorbed into the circulation. Drug Any chemical that affects the physiologic processes of a living organism. Drug actions The processes involved in the interaction between a drug and body cells (e.g., the action of a drug on a receptor protein); also called mechanism of action. Drug classification A method of grouping drugs; may be based on structure or therapeutic use. Drug effects The physiologic reactions of the body to a drug. They can be therapeutic or toxic and describe how the body is affected as a whole by the drug. Drug-induced teratogenesis The development of congenital anomalies or defects in the developing fetus caused by the toxic effects of drugs. 131 Drug interaction Alteration in the pharmacologic or pharmacokinetic activity of a given drug caused by the presence of one or more additional drugs; it is usually related to effects on the enzymes required for metabolism of the involved drugs. Duration of action The length of time the concentration of a drug in the blood or tissues is sufficient to elicit a response. Enzymes Protein molecules that catalyze one or more of a variety of biochemical reactions, including those related to the body's physiologic processes, as well as those related to drug metabolism. First-pass effect The initial metabolism in the liver of a drug absorbed from the gastrointestinal tract before the drug reaches systemic circulation through the bloodstream. Generic name The name given to a drug by the United States Adopted Names Council. Also called the nonproprietary name. The generic name is much shorter and simpler than the chemical name and is not protected by trademark. Glucose-6-phosphate dehydrogenase (G6PD) deficiency A hereditary condition in which red blood cells break down when the body is exposed to certain drugs. Half-life In pharmacokinetics, the time required for half of an administered dose of drug to be eliminated by the body, or the time it takes for the blood level of a drug to be reduced by 50% (also called elimination half-life). Idiosyncratic reaction An abnormal and unexpected response to a medication, other than an allergic reaction, that is peculiar to an individual patient. Incompatibility The characteristic that causes two parenteral drugs or solutions to undergo a reaction when mixed or given together that results in the chemical deterioration of at least one of the drugs. Intraarterial Within an artery (e.g., intraarterial injection). 132 Intraarticular Within a joint (e.g., intraarticular injection). Intrathecal Within a sheath (e.g., the theca of the spinal cord, as in an intrathecal injection into the subarachnoid space). Medication error Any preventable adverse drug event (see above) involving inappropriate medication use by a patient or health care professional; it may or may not cause patient harm. Medication use process The prescribing, dispensing, and administering of medications, and the monitoring of their effects. Metabolite A chemical form of a drug that is the product of one or more biochemical (metabolic) reactions involving the parent drug (see later). Active metabolites are those that have pharmacologic activity of their own, even if the parent drug is inactive (see prodrug). Inactive metabolites lack pharmacologic activity and are simply drug waste products awaiting excretion from the body (e.g., via the urinary, gastrointestinal, or respiratory tract). Onset of action The time required for a drug to elicit a therapeutic response after dosing. P-glycoprotein A transporter protein that moves drugs out of cells and into the gut, urine, or bile. Parent drug The chemical form of a drug that is administered before it is metabolized by the body into its active or inactive metabolites (see metabolite). A parent drug that is not pharmacologically active itself is called a prodrug. A prodrug is then metabolized to pharmacologically active metabolites. Peak effect The time required for a drug to reach its maximum therapeutic response in the body. Peak level The maximum concentration of a drug in the body after administration, usually measured in a blood sample for therapeutic drug monitoring. Pharmaceutics The science of preparing and dispensing drugs, including dosage form design. 133 Pharmacodynamics The study of the biochemical and physiologic interactions of drugs at their sites of activity. It examines the effect of the drug on the body. Pharmacoeconomics The study of economic factors impacting the cost of drug therapy. Pharmacogenomics The study of the influence of genetic factors on drug response that result in the absence, overabundance, or insufficiency of drug-metabolizing enzymes (also called pharmacogenomics; see Chapter 8). Pharmacognosy The study of drugs that are obtained from natural plant and animal sources. Pharmacokinetics The study of what happens to a drug from the time it is put into the body until the parent drug and all metabolites have left the body. Pharmacokinetics represent the drug absorption into, distribution and metabolism within, and excretion from the body. Pharmacology The broadest term for the study or science of drugs. Pharmacotherapeutics The treatment of pathologic conditions through the use of drugs. Prodrug An inactive drug dosage form that is converted to an active metabolite by various biochemical reactions once it is inside the body. Prototypical drug The first form of a drug, or first in a class of drugs. Throughout this book, prototypical drugs will be denoted as a “key drug.” Receptor A molecular structure within or on the outer surface of a cell. Receptors bind specific substances (e.g., drug molecules), and one or more corresponding cellular effects (drug actions) occur as a result of this drug-receptor interaction. Steady state The physiologic state in which the amount of drug removed via elimination is equal to the amount of drug absorbed with each dose. 134 Substrates Substances (e.g., drugs or natural biochemicals in the body) on which an enzyme acts. Synergistic effects Drug interactions in which the effect of a combination of two or more drugs with similar actions is greater than the sum of the individual effects of the same drugs given alone. For example, 1 + 1 is greater than 2 (compare with additive effects). Therapeutic drug monitoring The process of measuring drug levels to identify a patient's drug exposure and to allow adjustment of dosages with the goals of maximizing therapeutic effects and minimizing toxicity. Therapeutic effect The desired or intended effect of a particular medication. Therapeutic index The ratio between the toxic and therapeutic concentrations of a drug. Tolerance Reduced response to a drug after prolonged use. Toxic The quality of being poisonous (i.e., injurious to health or dangerous to life). Toxicity The condition of producing adverse bodily effects due to poisonous qualities. Toxicology The study of poisons, including toxic drug effects, and applicable treatments. Trade name The commercial name given to a drug product by its manufacturer; also called the proprietary name. Trough level The lowest concentration of drug reached in the body after it falls from its peak level, usually measured in a blood sample for therapeutic drug monitoring. Overview Any chemical that affects the physiologic processes of a living organism can be defined as a drug. The study or science of drugs is 135 known as pharmacology. Pharmacology encompasses a variety of topics, including the following: • Absorption • Biochemical effects • Biotransformation (metabolism) • Distribution • Drug history • Drug origin • Excretion • Mechanisms of action • Physical and chemical properties • Physical effects • Drug receptor mechanisms • Therapeutic (beneficial) effects • Toxic (harmful) effects Pharmacology includes the following several subspecialty areas: pharmaceutics, pharmacokinetics, pharmacodynamics, pharmacogenomics (pharmacogenetics), pharmacoeconomics, pharmacotherapeutics, pharmacognosy, and toxicology. Knowledge of pharmacology enables the nurse to better understand how drugs affect humans. Without understanding basic pharmacologic principles, the nurse cannot fully appreciate the therapeutic benefits and potential toxicity of drugs. Throughout the process of its development, a drug will acquire at least three different names. The chemical name describes the drug's chemical composition and molecular structure. The generic name, or nonproprietary name, is often much shorter and simpler than the chemical name. The generic name is used in most official drug compendiums to list drugs. The trade name, or proprietary name, is the drug's registered trademark, and indicates that its commercial use is restricted to the owner of the patent for the drug (Fig. 2.1). The patent owner is usually the manufacturer of the drug. Trade names are generally created by the manufacturer with 136 marketability in mind. For this reason, they are usually shorter and easier to pronounce and remember than generic drug names. The patent life (the length of time from patent approval until patent expiration) of a newly discovered drug molecule is normally 17 years. The research processes for new drug development normally require about 10 years, and the manufacturer generally has the remaining 7 years for sales profits before patent expiration. A significant amount of these profits serves to offset the multimilliondollar costs for research and development of the drug. A new category of the generic drug market is called biosimilars. Biosimilar, by definition, is a copy version of an already authorized biological product. FIG. 2.1 Chemical structure of the common analgesic ibuprofen and the chemical, generic, and trade names for the drug. After the patent expires, other manufacturers may legally begin to manufacture generic drugs with the same active ingredient. At this point, the drug price usually decreases substantially. Due to the high cost of drugs, many institutions have implemented programs in which one drug in a class of several drugs is chosen as the preferred agent, even though the drugs do not have the same active ingredients. This is called therapeutic equivalence. Before one drug can be therapeutically substituted for another, the drugs must have been proven to have the same therapeutic effect on the body. Drugs are grouped together based on their similar properties. This is known as a drug classification. Drugs can be classified by their structure (e.g., beta-adrenergic blockers) or by their therapeutic use (e.g., antibiotics, antihypertensives, antidepressants). Within the broad classification, each class may have subclasses; for example, penicillins are a subclass within the group of antibiotics, and beta-adrenergic blockers are a subclass 137 within the group of antihypertensives. Prototypical drugs are the first drug in a class of drugs and are noted as key drugs throughout this textbook. Three basic areas of pharmacology—pharmaceutics, pharmacokinetics, and pharmacodynamics—describe the relationship between the dose of a drug and the activity of that drug in treating the disorder. Pharmaceutics is the study of how various dosage forms influence the way in which the drug affects the body. Pharmacokinetics is the study of what the body does to the drug. Pharmacokinetics involves the processes of absorption, distribution, metabolism, and excretion. Pharmacodynamics is the study of what the drug does to the body. Pharmacodynamics involves drugreceptor relationships. Fig. 2.2 illustrates the three phases of drug activity, starting with the pharmaceutical phase, proceeding to the pharmacokinetic phase, and finishing with the pharmacodynamic phase. 138 FIG. 2.2 Phases of drug activity. (From McKenry, L. M., Tessier, E., & Hogan, M. (2006). Mosby's pharmacology in nursing (22nd ed.). St Louis: Mosby.) Pharmacotherapeutics (also called therapeutics) focuses on the clinical use of drugs to prevent and treat diseases. It defines the principles of drug actions. Some drug mechanisms of action are more clearly understood than others. Drugs are also categorized into pharmacologic classes according to their physiologic functions (e.g., beta-adrenergic blockers) and primary disease states treated (e.g., anticonvulsants, antiinfectives). The US Food and Drug Administration (FDA) regulates the approval and clinical use of all drugs in the United States, including the requirement of an expiration date on all drugs. This textbook focuses almost exclusively on current FDA-approved indications for the drugs discussed in each chapter and on drugs that are currently available in the United States at the time of this writing. Only FDA-approved 139 indications are permitted to be described in the manufacturer's written information, or labeling, for a given drug product. At times, prescribers may choose to use drugs for non–FDA-approved indications. This is known as off-label prescribing. Evolving over time in clinical practice, previously off-label indications often become FDA-approved indications for a given drug. The study of the adverse effects of drugs and other chemicals on living systems is known as toxicology. Toxic effects are often an extension of a drug's therapeutic action. Therefore toxicology frequently involves overlapping principles of both pharmacotherapy and toxicology. The study of natural (versus synthetic) drug sources (i.e., plants, animals, minerals) is called pharmacognosy. Pharmacoeconomics focuses on the economic aspects of drug therapy. In summary, pharmacology is a very dynamic science that incorporates several different disciplines, including chemistry, physiology, and biology. Pharmaceutics Different drug dosage forms have different pharmaceutical properties. Dosage form determines the rate at which drug dissolution (dissolving of solid dosage forms and their absorption, e.g., from the gastrointestinal [GI] tract) occurs. A drug to be ingested orally may be in either a solid form (tablet, capsule, or powder) or a liquid form (solution or suspension). Table 2.1 lists various oral drug preparations and the relative rate at which they are absorbed. Oral drugs that are liquids (e.g., elixirs, syrups) are already dissolved and are usually absorbed more quickly than solid dosage forms. Enteric-coated tablets, on the other hand, have a coating that prevents them from being broken down in the acidic pH environment of the stomach and are not absorbed until they reach the higher (more alkaline) pH of the intestines. This pharmaceutical property results in slower dissolution and therefore slower absorption. TABLE 2.1 Drug Absorption of Various Oral Preparations 140 Particle size within a tablet or capsule can make different dosage forms of the same drug dissolve at different rates, become absorbed at different rates, and thus have different times to onset of action. An example is the difference between micronized glyburide and nonmicronized glyburide. Micronized glyburide reaches a maximum concentration peak faster than does the nonmicronized formulation. Combination dosage forms contain multiple drugs in one dose— for example, the cholesterol and antihypertensive medications atorvastatin/amlodipine tablets called Caduet. There are large numbers of such combinations; examples are cited in the various chapters of this textbook. A variety of dosage forms exist to provide both accurate and convenient drug delivery systems (Table 2.2). These delivery systems are designed to achieve a desired therapeutic response with minimal adverse effects. Many dosage forms have been developed to encourage patient adherence with the medication regimen. Extended-release tablets and capsules release drug molecules in the patient's GI tract over a prolonged period. This ultimately prolongs drug absorption as well as duration of action. This is the opposite of immediate-release dosage forms, which release all of the active ingredient immediately upon dissolution in the GI tract. Extended-release dosage forms are normally easily identified by various capital letter abbreviations attached to their names. Examples of this nomenclature are SR (slow release or sustained release), SA (sustained action), CR (controlled release), XL (extended length), and XT (extended time). Convenience of administration correlates strongly with patient adherence, because these forms often require fewer daily doses. Extended-release oral dosage forms must not be crushed, as this could cause accelerated 141 release of drug from the dosage form and possible toxicity. Entericcoated tablets also are not recommended for crushing. This would cause disruption of the tablet coating designed to protect the stomach lining from the local effects of the drug and/or protect the drug from being prematurely disrupted by stomach acid. The ability to crush a tablet or open a capsule can facilitate drug administration when patients are unable or unwilling to swallow a tablet or capsule, and also when medications need to be given through an enteral feeding tube. Capsules, powder, or liquid contents can often be added to soft foods such as applesauce or pudding, or dissolved in a beverage. Granules contained in capsules are usually for extended drug release and normally should not be crushed or chewed by the patient. However, they can often be swallowed when sprinkled on one of the soft foods. Consultation with a pharmacist or use of other suitable source is necessary if any question exists as to whether a drug can be crushed or mixed with a specific food or beverage. TABLE 2.2 Dosage Forms Route Enteral Forms Tablets, capsules, oral soluble wafers, pills, timed-release capsules, timed-release tablets, elixirs, suspensions, syrups, emulsions, solutions, lozenges or troches, rectal suppositories, sublingual or buccal tablets Parenteral Injectable forms, solutions, suspensions, emulsions, powders for reconstitution Topical Aerosols, ointments, creams, pastes, powders, solutions, foams, gels, transdermal patches, inhalers, rectal and vaginal suppositories An increasingly popular dosage form is one that dissolves in the mouth and is absorbed through the oral mucosa. These include orally disintegrating tablets as well as thin wafers. Depending on the specific drug product, the dosage form may dissolve on the tongue, under the tongue, or in the buccal (cheek) pocket. The specific characteristics of the dosage form have a large impact on how and to what extent the drug is absorbed. For a drug to work at a specific site in the body, either it must be applied directly at the site in an active form or it must have a way of getting to that site. Oral dosage forms rely on gastric and intestinal 142 enzymes and pH environments to break the medication down into particles that are small enough to be absorbed into the circulation. Once absorbed through the mucosa of the stomach or intestines, the drug is then transported to the site of action by blood or lymph. Many topically applied dosage forms work directly on the surface of the skin. Once the drug is applied, it is in a form that allows it to act immediately. With other topical dosage forms, the skin acts as a barrier through which the drug must pass to get into the circulation; once there, the drug is then carried to its site of action (e.g., fentanyl transdermal patch for pain). Dosage forms that are administered via injection are called parenteral forms. They must have certain characteristics to be safe and effective. The arteries and veins that carry drugs throughout the body can easily be damaged if the drug is too concentrated or corrosive. The pH of injections must be very similar to that of the blood for these drugs to be administered safely. Parenteral dosage forms that are injected intravenously are immediately placed into solution in the bloodstream and do not have to be dissolved in the body. Therefore 100% absorption is assumed to occur immediately upon intravenous injection. Pharmacokinetics Pharmacokinetics is the study of what happens to a drug from the time it is put into the body until the parent drug and all metabolites have left the body. Specifically, the combined processes of pharmacokinetics include drug absorption into, distribution and metabolism within, and excretion from the body represent. Absorption Absorption is the movement of a drug from its site of administration into the bloodstream for distribution to the tissues. Bioavailability is the term used to express the extent of drug absorption. A drug that is absorbed from the intestine must first pass through the liver before it reaches the systemic circulation. If a large proportion of a drug is chemically changed into inactive metabolites in the liver, then a much smaller amount of drug will 143 pass into the circulation (i.e., will be bioavailable). Such a drug is said to have a high first-pass effect. First-pass effect reduces the bioavailability of the drug to less than 100%. Many drugs administered by mouth have a bioavailability of less than 100%, whereas drugs administered by the intravenous route are 100% bioavailable. If two drug products have the same bioavailability and same concentration of active ingredient, they are said to be bioequivalent (e.g., a brand-name drug and the same generic drug). Various factors affect the rate of drug absorption. How a drug is administered, or its route of administration, affects the rate and extent of absorption of that drug. Although a number of dosage formulations are available for delivering medications, they can all be categorized into three basic routes of administration: enteral (GI tract), parenteral, and topical. Case Study Patient-Centered Care: Pharmacokinetics © forestpath Four patients with angina are receiving a form of nitroglycerin, as follows: Mrs. A. takes 6.5 mg (extended release tablets) PO three times a day to prevent angina. Mr. B. takes a transdermal patch that delivers 0.2 mg/hr, also to prevent angina. Mrs. C. takes 0.4 mg sublingually, only if needed for chest 144 pain. Mr. D. is in the hospital with severe heart failure after a myocardial infarction, and is receiving 15 mcg/min via an intravenous infusion. You may refer to the section on nitroglycerin in Chapter 23 or to a nursing drug handbook to answer these questions. 1. For each patient, state the rationale for the route or form of drug that was chosen. Which forms have immediate action? Why would this be important? 2. Which form or forms are most affected by the first-pass effect? Explain your answer. 3. What would happen if Mrs. A. chewed her nitroglycerin dose? If Mrs. C. chewed her nitroglycerin dose? Enteral Route In enteral drug administration, the drug is absorbed into the systemic circulation through the mucosa of the stomach and/or small or large intestine. Orally administered drugs are absorbed from the intestinal lumen into the blood system and transported to the liver. Once the drug is in the liver, hepatic enzyme systems metabolize it, and the remaining active ingredients are passed into the general circulation. Many factors can alter the absorption of drugs, including acid changes within the stomach, absorption changes in the intestines, and the presence or absence of food and fluid. Various factors that affect the acidity of the stomach include the time of day; the age of the patient; and the presence and types of medications, foods, or beverages. Enteric coating is designed to protect the stomach by having drug dissolution and absorption occur in the intestines. Taking an enteric-coated medication with a large amount of food may cause it to be dissolved by acidic stomach contents and thus reduce intestinal drug absorption and negate the coating's stomach-protective properties. Anticholinergic drugs slow GI transit time (or the time it takes for substances in the stomach to be dissolved for transport to and absorption from the intestines). This may reduce the amount of drug absorption for acid-susceptible drugs that become broken down by stomach acids. 145 The presence of food may enhance the absorption of some fatsoluble drugs or of drugs that are more easily broken down in an acidic environment. Drug absorption may be altered in patients who have had portions of the small intestine removed because of disease. This is known as short bowel syndrome. Similarly, bariatric weight-loss surgery reduces the size of the stomach. As a result, medication absorption can be altered, because stomach contents are delivered to the intestines more rapidly than usual. This is called gastric dumping. Examples of drugs to be taken on an empty stomach and those to be taken with food are provided in Box 2.1. The stomach and small intestine are highly vascularized. When blood flow to this area is decreased, absorption may also be decreased. Sepsis and exercise are examples of circumstances under which blood flow to the GI tract is often reduced. In both cases, blood tends to be routed to the heart and other vital organs. In the case of exercise, it is also routed to the skeletal muscles. Box 2.1 Drugs to Be Taken on an Empty Stomach and Drugs to Be Taken With Food Many medications are taken on an empty stomach with at least 6 ounces of water. The nurse must give patients specific instructions regarding those medications that are not to be taken with food. Examples include alendronate sodium and risedronate sodium. Medications that are generally taken with food include carbamazepine, iron and iron-containing products, hydralazine, lithium, propranolol, spironolactone, nonsteroidal antiinflammatory drugs, and theophylline. Macrolides and oral opioids are often taken with food (even though they are specified to be taken with a full glass of water and on an empty stomach) to minimize the gastrointestinal irritation associated with these drugs. If doubt exists, consult a licensed pharmacist or a current authoritative drug resource. An Internet source to use is www.usp.org. 146 Rectally administered drugs are often given for systemic effects (e.g., antinausea, analgesia, antipyretic effects), but they are also used to treat disease within the rectum or adjacent bowel (e.g., antiinflammatory ointment for hemorrhoids). In this case, rectal administration may also be thought of as a topical route of drug administration. Sublingual and buccal routes. Drugs administered by the sublingual route are absorbed into the highly vascularized tissue under the tongue—the oral mucosa. Sublingual nitroglycerin is an example. Sublingually administered drugs are absorbed rapidly because the area under the tongue has a large blood supply. These drugs bypass the liver and yet are systemically bioavailable. The same applies for drugs administered by the buccal route (the oral mucosa between the cheek and the gum). Through these routes, drugs such as nitroglycerin are absorbed rapidly into the bloodstream and delivered to their site of action (e.g., coronary arteries). Parenteral Route The parenteral route is the fastest route by which a drug can be absorbed, followed by the enteral and topical routes. Parenteral is a general term meaning any route of administration other than the GI tract. It most commonly refers to injection. Intravenous injection delivers the drug directly into the circulation, where it is distributed with the blood throughout the body. Drugs given by intramuscular injection and subcutaneous injection are absorbed more slowly than those given intravenously. These drug formulations are usually absorbed over a period of several hours; however, some are specially formulated to be released over days, weeks, or months. Drugs can be injected intradermally, subcutaneously, intraarterially, intramuscularly, intrathecally, intraarticularly, or intravenously. Intraarterial, intrathecal, or intraarticular injections are usually given by physicians. Medications given by the parenteral route have the advantage of bypassing the first-pass effect of the liver. Parenteral administration offers an alternative route of delivery for medications that cannot be given orally. However, drugs that are administered by the parenteral route must 147 still be absorbed into cells and tissues before they can exert their pharmacologic effect (Table 2.3). TABLE 2.3 Routes of Administration and Related Nursing Considerations Route Intravenous (IV) Advantages Provides rapid onset (drug delivered immediately to bloodstream); allows more direct control of drug level in blood; gives option of larger fluid volume, therefore diluting irritating drugs; avoids first-pass metabolism Disadvantages Often of higher cost; requires intravenous access and not selfadministered; irreversibility of drug action in most cases and inability to retrieve medication; risk of fluid overload; greater likelihood of infection; possibility of embolism Intramuscular (IM); subcutaneous (subQ) Intramuscular injections are indicated/used with drugs that are poorly soluble which Discomfort of injection; if inaccurate technique or improper landmarking 148 Nursing Considerations Thorough handwashing and use of gloves. Continuous intravenous infusions require frequent monitoring to be sure that the correct volume and amount are administered and that the drug reaches safe, therapeutic blood levels. Intravenous drugs and solutions must be checked for compatibilities. Intravenous sites are to be monitored for redness, swelling, heat, and drainage—all indicative of complications, such as thrombophlebitis, infiltration, and infection. If intermittent intravenous infusions are used, clearing or flushing of the line with normal saline before and after is generally indicated to keep the intravenous site patent and minimize incompatibilities. Always check facility protocol on the length of time that an IV catheter may be left in the same site. Use a filter needle when withdrawing from an ampule or vial and replace with regular needle prior to use (for all parenterally administered drugs). Thorough handwashing and use of gloves. Use anatomical landmarks to identify correct intramuscular and subcutaneous sites is always required and recommended as are often given in “depot” preparation form and are then absorbed over a prolonged period; several drugs may be administered simultaneously if compatible in syringe and/or without contraindication; IM and subcutaneous routes result in more rapid absorption as compared with oral route Oral (PO) occurs, risks of damage to blood vessels, nerves, and surrounding tissue; IM and subcutaneous routes have slower onset of action as compared with intravenous; only small amounts of drugs may be given intramuscularly (up to 3 mL) and subcutaneously (up to 1 mL) a nursing standard of care (see Photo Atlas). For adults, potential intramuscular sites include the ventrogluteal, vastus lateralis, and deltoid. The dorsogluteal site is not recommended because of potential damage to nearby nerves and blood vessels. Use of a inch, 20 or 25 gauge needle; to 1 inch needle may be indicated in patients who are very thin or emaciated); a larger gauge needle (18–20) may be indicated with use of viscous or oil-based solutions. Subcutaneous injections may be given in the abdomen, thigh and upper arm and recommended to be given at a 90-degree angle with a proper size syringe and needle ( inch, 25-to 27-gauge); in emaciated or very thin patients, the subcutaneous angle is at 45 degrees. Subcutaneous route is selected for only a few drugs (i.e., insulin, heparin) due to irritability of drugs. Insulin syringes are marked in units and hold only 1 mL of medication and to be used only with insulin. Tuberculin syringes hold up to 1 mL of medicine. Selection of correct size of syringe and needle is key to safe administration by these routes and is based on thorough assessment of the patient as well as the characteristics of the drug. Usually easier, Variable Enteral routes include oral more absorption and administration and involve a convenient, and slow onset of variety of dosage forms (e.g., less expensive; action; liquids, solutions, tablets, and safer than inactivation of enteric-coated pills or tablets). injection, dosing some drugs by Some medications are 149 more likely to be reversible in cases of accidental ingestion (e.g., administration of activated charcoal). Does not require complex equipment. stomach acid and/or pH; problems with first-pass effect or presystemic metabolism; greater dependence of drug action on patient variables; some drugs irritate GI mucosa recommended to be taken with food, while others are recommended not to be taken with food; it is also suggested that oral dosage forms of drugs be taken with at least 6–8 ounces of fluid, such as water. Other factors to consider include other medicines being taken at the same time and concurrent use of dairy products or antacids. If oral forms are given via nasogastric tube or gastrostomy tube, tube placement in stomach must be assessed prior to giving the medication, and the patient's head is to remain elevated; flushing the nasogastric tube with at least 30–60 mL of water before and after the drug has been given is recommended to help maintain tube patency and prevent clogging. Sublingual, Absorbed more Patients may Drugs given via the sublingual buccal rapidly from swallow pill route are to be placed under the (subtypes of oral mucosa and instead of tongue; once dissolved, the oral, but more leads to more keeping under drug may be swallowed. When parenteral rapid onset of tongue until using the buccal route, than enteral) action; avoids dissolved; pills medication is placed between breakdown of often smaller to the cheek and gum. Both of drug by stomach handle these dosage forms are acid; avoids relatively nonirritating; the first-pass drug usually is without flavor metabolism and water-soluble. because gastric absorption is bypassed Rectal Provides Possible Absorption via this route is relatively rapid discomfort and erratic and unpredictable, but it absorption; good embarrassment provides a safe alternative alternative when to patient; often when nausea or vomiting oral route not higher cost than prevents oral dosing of drugs. feasible; useful oral route The patient must be placed on for local or his or her left side so that the systemic drug normal anatomy of the colon delivery; usually allows safe and effective leads to mixed insertion of the rectal dosage 150 first-pass and non–first-pass metabolism Topical Transdermal (subtype of topical) Inhalational form. Suppositories are inserted using a gloved hand and/or gloved index finger and watersoluble lubricant. The drug must be administered exactly as ordered. Delivers Sometimes Most dermatologic drugs are medication awkward to given via topical route in form directly to self-administer of a solution, ointment, spray, affected area; (e.g., eye or drops. Maximal absorption decreases drops); may of topical drugs is enhanced likelihood of irritate skin, with skin that is clean and free systemic drug may be messy; of debris; if measurement of effects usually higher ointment is necessary—such as cost than oral with topical nitroglycerin— route application must be done carefully and per instructions (e.g., apply 1 inch of ointment). Gloves help minimize crosscontamination and prevent absorption of drug into the nurse's own skin. If the patient's skin is not intact, sterile technique must be used. Provides Rate of Transdermal drugs are to be relatively absorption can placed on alternating sites and constant rate of be affected by on a clean, nonhairy, drug absorption; excessive nonirritated area, and only after one patch can perspiration the previously applied patch last 1–7 days, and body has been removed and that area depending on temperature; cleansed and dried. drug; avoids patch may peel Transdermal drugs generally first-pass off; cost is come in a single-dose, adhesivemetabolism higher; used backed drug application patches must be system. disposed of safely; may irritate skin; if skin is inflamed, abraded, or damaged, drug absorption may be increased leading to systemic side effects Provides rapid Rate of Inhaled medications are to be 151 absorption; drug delivered directly to lung tissues where most of these drugs exert their actions absorption can be too rapid, increasing the risk for exaggerated drug effects; requires more patient education for selfadministration; some patients may have difficulty with administration technique used exactly as prescribed and with clean equipment. Instructions need to be given to the patient/family/caregiver regarding medications to be used as well as the proper use, storage, and safe-keeping of inhalers, spacers, and nebulizers. Chapter 9 describes how medications are inhaled and the various inhaled dosage forms. GI, Gastrointestinal. NOTE: Refer to Chapter 9 for more specific instructions, diagrams, and pictures of some of the different routes of administration. For more information on avoiding the use of abbreviations associated with dosage routes, dosage amounts, dosage frequency, and drug names, as well as the use of symbols, please visit www.ismp.org/tools/errorproneabbreviations.pdf. Safety and Quality Improvement: Preventing Medication Errors Does IV = PO? The prescriber writes an order for “Lasix 80 mg IV STAT × 1 dose” for a patient who is short of breath with heart failure. When the nurse goes to give the drug, only the PO form is immediately available. Someone must go to the pharmacy to pick up the IV dose. Another nurse says, “Go ahead and give the pill. He needs it fast. It's all the same!” But is it? Remember, the oral forms of medications must be processed through the gastrointestinal tract, absorbed through the small intestines, and undergo the first-pass effect in the liver before the drug can reach the intended site of action. However, IV forms are injected directly into the circulation and can act almost 152 immediately because the first-pass effect is bypassed. The time until onset of action for the PO form is 30 to 60 minutes; for the IV form, this time is 5 minutes. This patient is in respiratory distress, and the immediate effect of the diuretic is desired. In addition, because of the first-pass effect, the available amount of orally administered drug that actually reaches the site of action would be less than the available amount of intravenously administered drug. Therefore IV does NOT equal PO! Never change the route of administration of a medication; if questions come up, always check with the prescriber. Subcutaneous, intradermal, and intramuscular routes. Injections into the fatty subcutaneous tissues under the dermal layer of skin are referred to as subcutaneous injections. Injections under the more superficial skin layers immediately underneath the epidermal layer of skin and into the dermal layer are known as intradermal injections. Injections given into the muscle beneath the subcutaneous fatty tissue are referred to as intramuscular injections. Muscles have a greater blood supply than does the skin; therefore drugs injected intramuscularly are absorbed faster than drugs injected subcutaneously. Absorption from either of these sites may be increased by applying heat to the injection site or by massaging the site. In contrast, the presence of cold, hypotension, or poor peripheral blood flow compromises the circulation, reducing drug activity by reducing drug delivery to the tissues. Most intramuscularly injected drugs are absorbed over several hours. However, specially formulated long-acting intramuscular dosage forms called depot drugs have been designed for slow absorption over a period of several days to a few months or longer. Topical Route The topical route of drug administration involves application of medications to various body surfaces. Several topical drug delivery systems exist. Topically administered drugs can be applied to the skin, eyes, ears, nose, lungs, rectum, or vagina. Topical application delivers a uniform amount of drug over a longer period, but the effects of the drug are usually slower in their onset and more prolonged in their duration of action as compared with oral or 153 parenteral administration. This can be a problem if the patient begins to experience adverse effects from the drug and a considerable amount of drug has already been absorbed. All topical routes of drug administration avoid first-pass effects of the liver, with the exception of rectal administration. Because the rectum is part of the GI tract, some drug will be absorbed into the capillaries that feed the portal vein to the liver. However, some drugs will also be absorbed locally into perirectal tissues. Therefore rectally administered drugs are said to have a mixed first-pass and non– first-pass absorption and metabolism. Box 2.2 lists the various drug routes and indicates whether they are associated with first-pass effects in the liver. Box 2.2 Drug Routes and First-Pass Effects First-Pass Routes Hepatic arterial Oral Portal venous Rectala Non–First-Pass Routes Aural (instilled into the ear) Buccal Inhaled Intraarterial Intramuscular Intranasal Intraocular Intravaginal Intravenous Subcutaneous Sublingual 154 Transdermal aLeads to both first-pass and non–first-pass effects. Ointments, gels, and creams are common types of topically administered drugs. Examples include sunscreens, antibiotics, and nitroglycerin ointment. The drawback to their use is that their systemic absorption is often erratic and unreliable. In general, these medications are used for local effects, but some are used for systemic effects (e.g., nitroglycerin ointment for maintenance treatment of angina). Topically applied drugs can also be used in the treatment of various illnesses of the eyes, ears, and sinuses. Eye, ear, and nose drops are administered primarily for local effects, whereas nasal sprays may be used for both systemic and local effects. Vaginal medications may be given for systemic effects (e.g., progestational hormone therapy with progesterone vaginal suppositories) but are more commonly used for local effects (e.g., treatment of vaginal yeast infection with miconazole [Monistat] vaginal cream). Transdermal route. Transdermal drug delivery through adhesive patches is an elaborate topical route of drug administration that is commonly used for systemic drug effects. Transdermal patches are usually designed to deliver a constant amount of drug per unit of time for a specified time period. For example, a nitroglycerin patch may deliver 0.1 or 0.2 mg/h over 24 hours, whereas a fentanyl patch may deliver 25 to 100 mcg/h over a 72-hour period. This route is suitable for patients who cannot tolerate oral administration and provides a practical and convenient method for drug delivery. Inhaled route. Inhalation is another type of topical drug administration. Inhaled drugs are delivered to the lungs as micrometer-sized drug particles. This small drug size is necessary for the drug to be transported to the small air sacs within the lungs (alveoli). Once the small particles 155 of drug are in the alveoli, drug absorption is fairly rapid. Many pulmonary and other types of diseases can be treated with such topically applied (inhaled) drugs. Distribution Distribution refers to the transport of a drug by the bloodstream to its site of action (Fig. 2.3). Drugs are distributed first to those areas with extensive blood supply. Areas of rapid distribution include the heart, liver, kidneys, and brain. Areas of slower distribution include muscle, skin, and fat. Once a drug enters the bloodstream (circulation), it is distributed throughout the body. At this point, it is also starting to be eliminated by the organs that metabolize and excrete drugs—primarily the liver and the kidneys. Only drug molecules that are not bound to plasma proteins can freely distribute to extravascular tissue (outside the blood vessels) to reach their site of action. If a drug is bound to plasma proteins, the drugprotein complex is generally too large to pass through the walls of blood capillaries into tissues (Fig. 2.4). Albumin is the most common blood protein and carries the majority of protein-bound drug molecules. If a given drug binds to albumin, then there is only a limited amount of drug that is not bound. This unbound portion is pharmacologically active and is considered “free” drug, whereas “bound” drug is pharmacologically inactive. Certain conditions that cause low albumin levels, such as extensive burns and malnourished states, result in a larger fraction of free (unbound and active) drug. This can raise the risk for drug toxicity. 156 FIG. 2.3 Drug transport in the body.GI, Gastrointestinal. 157 FIG. 2.4 Protein binding of drugs. Albumin is the most prevalent protein in plasma and the most important of the proteins to which drugs bind. Only unbound (free) drug molecules can leave the vascular system. Bound molecules are too large to fit through the pores in the capillary wall. When an individual is taking two medications that are highly protein bound, the medications may compete for binding sites on the albumin molecule. Because of this competition, there is more free or unbound drug. Protein binding may lead to an unpredictable drug response called a drug-drug interaction. A drugdrug interaction occurs when the presence of one drug decreases or increases the actions of another drug that is administered concurrently (i.e., given at the same time). A theoretical volume, called the volume of distribution, is sometimes used to describe the various areas in which drugs may be distributed. These areas, or compartments, may be the blood (intravascular space), total body water, body fat, or other body tissues and organs. Typically a drug that is highly water-soluble (hydrophilic) will have a smaller volume of distribution and high blood concentrations. In contrast, fat-soluble drugs (lipophilic) have a larger volume of distribution and low blood concentrations. There are some sites in the body into which it may be very difficult to distribute a drug. These sites typically either have a poor blood supply (e.g., bone) or have physiologic barriers that make it difficult for drugs to pass through (e.g., the brain due to the blood-brain barrier). Metabolism Metabolism is also referred to as biotransformation. It involves the biochemical alteration of a drug into an inactive metabolite, a more soluble compound, a more potent active metabolite (as in the conversion of an inactive prodrug to its active form), or a less active metabolite. Metabolism is the next pharmacokinetic step after absorption and distribution. The organ most responsible for the metabolism of drugs is the liver. Other metabolic tissues include skeletal muscle, kidneys, lungs, plasma, and intestinal mucosa. 158 Hepatic metabolism involves the activity of a very large class of enzymes known as cytochrome P-450 enzymes (or simply P-450 enzymes), also known as microsomal enzymes. These enzymes control a variety of reactions that aid in the metabolism of drugs. They target lipid-soluble drugs (also known as lipophilic [“fat loving”]) that are typically very difficult to eliminate. The P-450 enzymes are responsible for the metabolism of the majority of medications. Medications with water-soluble (hydrophilic [“water loving”]) molecules may be more easily metabolized by simpler chemical reactions such as hydrolysis. Some of the chemical reactions by which the liver can metabolize drugs are listed in Table 2.4. Drug molecules that are the metabolic targets of specific enzymes are said to be substrates for those enzymes. Specific P-450 enzymes are identified by standardized number and letter designations. Some of the most common P-450 enzymes and their corresponding drug substrates are listed in Table 2.5. The P-450 system is one of the most important systems that influences drugdrug interactions. The list of drugs that are metabolized by the P450 enzyme system is constantly changing as new drugs are introduced into the market. For further information, see websites such as www.medicine.iupui.edu/clinpharm/ddis/ and www.nursinglink.com/training/articles/320-clinically-significant-druginteraction-with-the-cytochrome-p450-enzyme-system. Another common drug interaction involves a plasma membrane protein, Pglycoprotein, which acts as a drug transport mechanism, transporting drugs out of the cell. Many drugs can be impacted at the P-glycoprotein level. Metabolizing capabilities of the liver can vary considerably from patient to patient. Various factors that alter the biotransformation including genetics, diseases, and the concurrent use of other medications (Table 2.6). TABLE 2.4 Mechanisms of Biotransformation Type of Biotransformation Oxidation Reduction Hydrolysis Mechanism Result Chemical reactions Increase polarity of chemical, making it more water-soluble and more easily excreted. This often 159 Conjugation (e.g., glucuronidation, glycination, sulfation, methylation, alkylation) Combination with another substance (e.g., glucuronide, glycine, sulfate, methyl groups, alkyl groups) results in a loss of pharmacologic activity. Forms a less toxic product with less activity. TABLE 2.5 Common Liver Cytochrome P-450 Enzymes and Corresponding Drug Substrates Enzyme 1A2 2C9 2C19 2D6 2E1 3A4 Common Drug Substrates acetaminophen, caffeine, theophylline, warfarin ibuprofen, phenytoin diazepam, naproxen, omeprazole, propranolol codeine, fluoxetine, hydrocodone, metoprolol, oxycodone, paroxetine, risperidone, tricyclic antidepressants acetaminophen, ethanol acetaminophen, amiodarone, cyclosporine, diltiazem, ethinyl estradiol, indinavir, lidocaine, macrolides, progesterone, spironolactone, sulfamethoxazole, testosterone, verapamil TABLE 2.6 Examples of Conditions and Drugs That Affect Drug Metabolism Category Example Diseases Cardiovascular dysfunction Renal insufficiency Starvation Obstructive jaundice Genetic constitution Fast acetylator Slow acetylator Barbiturates rifampin (P-450 inducer) phenytoin (P-450 inducer) ketoconazole (P-450 inhibitor) Conditions Drugs DRUG METABOLISM Increased Decreased X X X X X X X X X X Many drugs can inhibit drug-metabolizing enzymes and are 160 called enzyme inhibitors. Decreases in drug metabolism result in the accumulation of the drug and prolongation of the effects of the drug, which can lead to drug toxicity. In contrast, drugs that stimulate drug metabolism are called enzyme inducers. This can cause decreased pharmacologic effects. This often occurs with the repeated administration of certain drugs that stimulate the formation of new microsomal enzymes. Excretion Excretion is the elimination of drugs from the body. All drugs, whether they are parent compounds, or active or inactive metabolites, must eventually be removed from the body. The primary organ responsible for this elimination is the kidney. Two other organs that play a role in the excretion of drugs are the liver and the bowel. Most drugs are metabolized in the liver by various mechanisms. Therefore, by the time most drugs reach the kidneys, they have undergone extensive biotransformation, and only a relatively small fraction of the original drug is excreted as the original compound. Other drugs may bypass hepatic metabolism and reach the kidneys in their original form. Drugs that have been metabolized by the liver become more polar and water-soluble. This makes their elimination by the kidneys much easier, because the urinary tract is water-based. The kidneys themselves are also capable of metabolizing various drugs, although usually to a lesser extent than the liver. The actual act of renal excretion is accomplished through glomerular filtration, active tubular reabsorption, and active tubular secretion. Free (unbound) water-soluble drugs and metabolites go through passive glomerular filtration. Many substances present in the nephrons go through active reabsorption and are taken back up into the systemic circulation and transported away from the kidney. This process is an attempt by the body to retain needed substances. Some substances may also be secreted into the nephron from the vasculature surrounding it. The processes of filtration, reabsorption, and secretion for urinary elimination are shown in Fig. 2.5. 161 FIG. 2.5 Renal drug excretion. The primary processes involved in drug excretion and the approximate location where these processes take place in the kidney are illustrated. GFR, Glomerular filtration rate. The excretion of drugs by the intestines is another route of elimination. This process is referred to as biliary excretion. Drugs that are eliminated by this route are taken up by the liver, released into the bile, and eliminated in the feces. Once certain drugs, such as fat-soluble drugs, are in the bile, they may be reabsorbed into the bloodstream, returned to the liver, and again secreted into the bile. This process is called enterohepatic recirculation. Enterohepatically recirculated drugs persist in the body for much longer periods. Less 162 common routes of elimination are the lungs and the sweat, salivary, and mammary glands. Half-Life Another pharmacokinetic variable is the half-life of the drug. By definition, half-life is the time required for one-half (50%) of a given drug to be removed from the body. It is a measure of the rate at which the drug is eliminated from the body. For instance, if the peak level of a drug is 100 mg/L and the measured drug level in 8 hours is 50 mg/L, then the estimated half-life of that drug is 8 hours. The concept of drug half-life viewed from several different perspectives is shown in Table 2.7. TABLE 2.7 Example of Drug Half-Life Viewed From Different Perspectives Metric Hours after peak concentration Drug concentration (mg/L) Number of half-lives Percentage of drug removed Changing Values 0 8 16 100 (peak) 50 25 0 1 2 0 50 75 24 12.5 3 88 32 6.25 4 94 40 3.125 (trough) 5 97 After about five half-lives, most drugs are considered to be effectively removed from the body. At that time approximately 97% of the drug has been eliminated, and what little amount remains is usually too small to have either therapeutic or toxic effects. The concept of half-life is clinically useful for determining when steady state will be reached. Steady state refers to the physiologic state in which the amount of drug removed via elimination (e.g., renal clearance) is equal to the amount of drug absorbed with each dose. This physiologic plateau phenomenon typically occurs after four to five half-lives of administered drug. Therefore, if a drug has an extremely long half-life, it will take much longer for the drug to reach steady-state blood levels. Once steady-state blood levels have been reached, there are consistent levels of drug in the body that correlate with maximum therapeutic benefits. 163 Onset, Peak, and Duration The pharmacokinetic terms absorption, distribution, metabolism, and excretion are all used to describe the movement of drugs through the body. Drug actions are the processes involved in the interaction between a drug and a cell (e.g., a drug's action on a receptor). In contrast, drug effects are the physiologic reactions of the body to the drug. The terms onset, peak, duration, and trough are used to describe drug effects. Peak and trough are also used to describe drug concentrations, which are usually measured from blood samples. A drug's onset of action is the time required for the drug to elicit a therapeutic response. A drug's peak effect is the time required for a drug to reach its maximum therapeutic response. Physiologically this corresponds to increasing drug concentrations at the site of action. The duration of action of a drug is the length of time that the drug concentration is sufficient (without more doses) to elicit a therapeutic response. These concepts are illustrated in Fig. 2.6. FIG. 2.6 Characteristics of drug effect and relationship to the therapeutic window. MEC, Minimal effective concentration. The length of time until the onset and peak of action and the duration of action play an important part in determining the peak level (highest blood level) and trough level (lowest blood level) of a drug. If the peak blood level is too high, then drug toxicity may 164 occur. The toxicity may be mild, such as intensification of the effects of the given drug (e.g., excessive sedation resulting from overdose of a drug with sedative properties). However, it can also be severe (e.g., damage to vital organs due to excessive drug exposure). If the trough blood level is too low, then the drug may not be at therapeutic levels to produce a response. In therapeutic drug monitoring, peak (highest) and trough (lowest) values are measured to verify adequate drug exposure, maximize therapeutic effects, and minimize drug toxicity. This monitoring is often carried out by a clinical pharmacist. Pharmacodynamics Pharmacodynamics relates to the mechanisms of drug action in living tissues. Drug-induced changes in normal physiologic functions are explained by the principles of pharmacodynamics. A positive change in a faulty physiologic system is called a therapeutic effect of a drug. Such an effect is the goal of drug therapy. Mechanism of Action Drugs can produce actions (therapeutic effects) in several ways. The effects of a particular drug depend on the characteristics of the cells or tissue targeted by the drug. Once the drug is at the site of action, it can modify (increase or decrease) the rate at which that cell or tissue functions, or it can modify the strength of function of that cell or tissue. A drug cannot, however, cause a cell or tissue to perform a function that is not part of its natural physiology. Drugs can exert their actions in three basic ways: through receptors, enzymes, and nonselective interactions. Not all mechanisms of action have been identified for all drugs. Thus a drug may be said to have an unknown mechanism of action, even though it has observable therapeutic effects in the body. Receptor Interactions A receptor can be defined as a reactive site on the surface or inside of a cell. If the mechanism of action of a drug involves a receptor 165 interaction, then the molecular structure of the drug is critical. Drug-receptor interaction is the joining of the drug molecule with a reactive site on the surface of a cell or tissue. Most commonly, this site is a protein structure within the cell membrane. Once a drug binds to and interacts with the receptor, a pharmacologic response is produced (Fig. 2.7). The degree to which a drug attaches to and binds with a receptor is called its affinity. The drug with the best “fit” and strongest affinity for the receptor will elicit the greatest response. A drug becomes bound to the receptor through the formation of chemical bonds between the receptor on the cell and the active site on the drug molecule. Drugs interact with receptors in different ways either to elicit or to block a physiologic response. Table 2.8 describes the different types of drug-receptor interaction. FIG. 2.7 Drugs act by forming a chemical bond with specific receptor sites, similar to a key and lock. The better the “fit,” the better the response. Drugs with complete attachment and response are called agonists. Drugs that attach but do not elicit a response are called antagonists. TABLE 2.8 Drug-Receptor Interactions Drug Type Action 166 Agonist Partial agonist (agonist-antagonist) Antagonist Competitive antagonist Noncompetitive antagonist Drug binds to the receptor; there is a response. Drug binds to the receptor; the response is diminished compared with that elicited by an agonist. Drug binds to the receptor; there is no response. Drug prevents binding of agonists. Drug competes with the agonist for binding to the receptor. If it binds, there is no response. Drug combines with different parts of the receptor and inactivates it; agonist then has no effect. Enzyme Interactions Enzymes are the substances that catalyze nearly every biochemical reaction in a cell. Drugs can produce effects by interacting with these enzyme systems. For a drug to alter a physiologic response in this way, it may either inhibit (more common) or enhance (less common) the action of a specific enzyme. This process is called selective interaction. Drug-enzyme interaction occurs when the drug chemically binds to an enzyme molecule in such a way that it alters (inhibits or enhances) the enzyme's interaction with its normal target molecules in the body. Nonselective Interactions Drugs with nonspecific mechanisms of action do not interact with receptors or enzymes. Instead, their main targets are cell membranes and various cellular processes such as metabolic activities. These drugs can either physically interfere with or chemically alter cellular structures or processes. Some cancer drugs and antibiotics have this mechanism of action. By incorporating themselves into the normal metabolic process, they cause a defect in the final product or state. This defect may be an improperly formed cell wall that results in cell death through cell lysis, or it may be the lack of a necessary energy substrate, which leads to cell starvation and death. Pharmacotherapeutics Before drug therapy is initiated, an end point or expected outcome of therapy needs to be established. This desired therapeutic 167 outcome is patient-specific, established in collaboration with the patient, and if appropriate, determined with other members of the health care team. Outcomes need to be clearly defined and must be either measurable or observable by monitoring. Outcome goals must be realistic and prioritized so that drug therapy begins with interventions that are essential to the patient's well-being. Examples include curing a disease, eliminating or reducing a preexisting symptom, arresting or slowing a disease process, preventing a disease or other unwanted condition, or otherwise improving quality of life. These goals and outcomes are not the same as nursing goals and outcomes. See Chapter 1 for a more specific discussion of the nursing process. Patient therapy assessment is the process by which a practitioner integrates his or her knowledge of medical and drug-related facts with information about a specific patient's medical and social history. Items to be considered in the assessment are drugs currently used (prescription, over-the-counter, herbal, and illicit or street drugs), pregnancy and breastfeeding status, and concurrent illnesses that could contraindicate initiation of a given medication. A contraindication for a medication is any patient condition, especially a disease state that makes the use of the given medication dangerous for the patient. Careful attention to this assessment process helps ensure an optimal therapeutic plan. The implementation of a treatment plan can involve several types and combinations of therapies. The type of therapy can be categorized as acute, maintenance, supplemental (or replacement), palliative, supportive, prophylactic, or empiric. Acute Therapy Acute therapy often involves more intensive drug treatment and is implemented in the acutely ill (those with rapid onset of illness) or the critically ill. It is often needed to sustain life or treat disease. Examples are the administration of vasopressors to maintain blood pressure, the use of volume expanders for a patient who is in shock, and intensive chemotherapy for a patient with newly diagnosed cancer. 168 Maintenance Therapy Maintenance therapy does not eradicate preexisting problems the patient may have, but will prevent progression of a disease or condition. It is used for the treatment of chronic illnesses such as hypertension. In this case, maintenance therapy maintains the patient's blood pressure within given limits, which prevents certain end-organ damage. Another example of maintenance therapy is the use of oral contraceptives for birth control. Supplemental Therapy Supplemental (or replacement) therapy supplies the body with a substance needed to maintain normal function. This substance may be needed either because it cannot be made by the body or because it is produced in insufficient quantity. Examples are the administration of insulin to diabetic patients and of iron to patients with iron-deficiency anemia. Palliative Therapy The goal of palliative therapy is to make the patient as comfortable as possible. Palliative therapy focuses on providing patients with relief from the symptoms, pain, and stress of a serious illness. The goal is to improve quality of life for both the patient and the family. It is typically used in the end stages of an illness when attempts at curative therapy have failed; however, it can be provided along with curative treatment. An example is the use of high-dose opioid analgesics to relieve pain in the final stages of cancer. Supportive Therapy Supportive therapy maintains the integrity of body functions while the patient is recovering from illness or trauma. Examples are provision of fluids and electrolytes to prevent dehydration in a patient who is vomiting and has diarrhea, administration of fluids, volume expanders, or blood products to a patient who has lost blood during surgery. 169 Prophylactic Therapy and Empiric Therapy Prophylactic therapy is drug therapy provided to prevent illness or other undesirable outcome during planned events. A common example is the use of preoperative antibiotic therapy for surgical procedures. The antibiotic is given before the incision is made, so that the antibiotic can kill any potential pathogens. Another example is the administration of disease-specific vaccines to individuals traveling to geographic areas where a given disease is known to be endemic. Empiric therapy is based on clinical probabilities. It involves drug administration when a certain pathologic condition has a high likelihood of occurrence based on the patient's initial presenting symptoms. A common example is use of antibiotics active against the organism most commonly associated with a specific infection before the results of the culture and sensitivity reports are available. Monitoring Once the appropriate therapy has been implemented, the effectiveness of the therapy—that is, the clinical response of the patient to the treatment—must be evaluated. Evaluating the clinical response requires familiarity with both the drug's intended therapeutic action (beneficial effects) and its unintended possible adverse effects (predictable adverse drug reactions [ADRs]). Examples of monitoring include observing for the therapeutic effect of reduced blood pressure following administration of antihypertensive drugs and observing for the toxic effect of leukopenia after administering antineoplastic (cancer chemotherapy) drugs. Another example is performing a pain assessment after giving pain medication. It should be noted that this textbook highlights only the most common adverse effects of a given drug; however, the drug may have many other less commonly reported adverse effects. Consult comprehensive references or a pharmacist when there is uncertainty regarding adverse effects that a patient may be experiencing. All drugs are potentially toxic and can have cumulative effects. Recognizing these toxic effects and knowing their manifestations are integral components of the monitoring process. A drug can 170 accumulate when it is absorbed more quickly than it is eliminated or when it is administered before the previous dose has been metabolized or cleared from the body. Knowledge of the organs responsible for metabolizing and eliminating a drug combined with knowledge of how a particular drug is metabolized and excreted enables the nurse to anticipate problems and treat them appropriately if they occur. Therapeutic Index The ratio of a drug's toxic level to the level that provides therapeutic benefits is referred to as the drug's therapeutic index. The safety of a particular drug therapy is determined by this index. A low therapeutic index means that the difference between a therapeutically active dose and a toxic dose is small. A drug with a low therapeutic index has a greater likelihood than other drugs of causing an adverse reaction, and therefore requires closer monitoring. Examples of such drugs are warfarin and digoxin. In contrast, a drug with a high therapeutic index, such as amoxicillin, is rarely associated with overdose events. Drug Concentration All drugs reach a certain concentration in the blood. Drug concentrations can be an important tool for evaluating the clinical response to drug therapy. Certain drug levels are associated with therapeutic responses, whereas other drug levels are associated with toxic effects. Toxic drug levels are typically seen when the body's normal mechanisms for metabolizing and excreting drugs are compromised. This commonly occurs when liver and kidney functions are impaired or when the liver or kidneys are immature (as in neonates). Dosage adjustments should be made in these patients to appropriately accommodate their impaired metabolism and excretion. Patient's Condition Another patient-specific factor to be considered is the patient's concurrent diseases or other medical conditions. A patient's response to a drug may vary greatly, depending on physiologic and 171 psychological demands. Disease of any kind, infection, cardiovascular function, and GI function can alter a patient's therapeutic response. Stress, depression, and anxiety can also be important psychological factors affecting response. Tolerance and Dependence To provide optimal drug therapy, it is important to understand and differentiate between tolerance and dependence. Tolerance is a decreasing response to repeated drug doses. Dependence is a physiologic or psychological need for a drug. Physical dependence is the physiologic need for a drug to avoid physical withdrawal symptoms (e.g., tachycardia in an opioid-addicted patient). Psychological dependence is also known as addiction and is the obsessive desire for the euphoric effects of a drug. Addiction typically involves the recreational use of various drugs such as benzodiazepines, opioids, and amphetamines. See Chapter 17 for further discussion of dependence and addiction. Interactions Drugs may interact with other drugs, with foods, or with agents administered as part of laboratory tests. Knowledge of drug interactions is vital for the appropriate monitoring of drug therapy. The more drugs a patient receives, the more likely that a drug interaction will occur. This is especially true in older adults, who typically have an increased sensitivity to drug effects and are receiving several medications. In addition, over-the-counter medications and herbal therapies and food can interact significantly with prescribed medications. See Table 2.9 for common food and drug interactions. TABLE 2.9 Common Food and Drug Interactions Food Drug (Category) Leafy warfarin (anticoagulant) green vegetables Result Decreased anticoagulant effect from warfarin 172 Dairy products tetracycline, levofloxacin, ciprofloxacin, moxifloxacin (antibiotics) Grapefruit amiodarone (antidysrhythmic), buspirone juice (antianxiety), carbamazepine (antiseizure), cyclosporine, tacrolimus (immunosuppressants), felodipine, nifedipine, nimodipine, nisoldipine (calcium channel blockers), simvastatin, atorvastatin (anticholesterol drugs) Aged Monoamine oxidase inhibitors cheese, wine Chemical binding of the drug leading to decreased effect and treatment failures Decreased metabolism of drugs and increased effects Hypertensive crisis Alteration of the action of one drug by another is referred to as drug interaction. A drug interaction can either increase or decrease the actions of one or both of the involved drugs. Drug interactions can be either beneficial or harmful. Numerous drug interactions can occur and have been reported. Only those drug interactions that are considered to be significant with a good probability of occurring and/or those that require dosage/therapy adjustment are discussed in this textbook. An authoritative resource may be used as a means of exploring all possible drug interactions. Concurrently administered drugs may interact with each other and alter the pharmacokinetics of one another during any of the four phases of pharmacokinetics: absorption, distribution, metabolism, or excretion. Table 2.10 provides examples of drug interactions during each of these phases. Most commonly, drug interactions occur when there is competition between two drugs for metabolizing enzymes, such as the cytochrome P-450 enzymes listed in Table 2.5. As a result, the speed of metabolism of one or both drugs may be enhanced or reduced. This change in metabolism of one or both drugs can lead to subtherapeutic or toxic drug actions. TABLE 2.10 Examples of Drug Interactions and Their Effects on Pharmacokinetics Pharmacokinetic Drug 173 Phase Combination Mechanism Result Absorption antacid with levofloxacin Decreased effectiveness of levofloxacin, resulting from decreased blood levels (harmful) Distribution warfarin with amiodarone Metabolism erythromycin Both drugs with compete for the cyclosporine same hepatic enzymes. amoxicillin Inhibits the with secretion of probenecid amoxicillin into the kidneys. Excretion Antacids bind to the levofloxacin, preventing adequate absorption. Both drugs compete for protein-binding sites. Higher levels of free (unbound) warfarin and amiodarone, which increases actions of both drugs (harmful) Decreased metabolism of cyclosporine, possibly resulting in toxic levels of cyclosporine (harmful) Elevation and prolongation of plasma levels of amoxicillin (can be beneficial) Many terms are used to categorize drug interactions. When two drugs with similar actions are given together, they can have additive effects (1 + 1 = 2). Often drugs are used together for their additive effects so that smaller doses of each drug can be given. Synergistic effects occur when two drugs administered together interact in such a way that their combined effects are greater than the sum of the effects for each drug given alone (1 + 1 = greater than 2). Antagonistic effects are said to occur when the combination of two drugs results in drug effects that are less than the sum of the effects for each drug given separately (1 + 1 = less than 2). Incompatibility is a term most commonly used to describe parenteral drugs. Drug incompatibility occurs when two parenteral drugs or solutions are mixed together, and the result is a chemical deterioration of one or both of the drugs or the formation of a physical precipitate. The combination of two such drugs usually produces a precipitate, haziness, or color change in the solution. Before administering any intravenous medication, the nurse must always inspect the bag for precipitate. If the solution appears cloudy or if visible flecks are seen, the bag must be discarded. Adverse Drug Events 174 The recognition of the potential hazards and detrimental effects of medication use is a topic that continues to receive much attention. This focus has contributed to an increasing body of knowledge regarding this topic, as well as the development of new terminology. Adverse drug event (ADE) is a broad term for any undesirable occurrence involving medications. A similarly broad term also seen in the literature is drug misadventure. Patient outcomes associated with ADEs vary from no effects to mild discomfort to lifethreatening complications, permanent disability, disfigurement, or death. ADEs can be preventable (see the discussion of medication errors in Chapter 5) or nonpreventable. Fortunately, many ADEs result in no measurable patient harm. ADEs can be both external and internal. The most common causes of ADEs external to the patient are errors by caregivers (both professional and nonprofessional) or malfunctioning of equipment (e.g., intravenous infusion pumps). An ADE can be internal, or patient induced, such as when a patient fails to take medication as prescribed or drinks alcoholic beverages that he or she was advised not to consume while taking a given medication. An impending ADE that is noticed before it actually occurs is considered a potential ADE (and appropriate steps must be taken to avoid such a “near miss” in the future). A less common situation, but one still worth mentioning, is an adverse drug withdrawal event. This is an adverse outcome associated with discontinuation of drug therapy, such as hypertension caused by abruptly discontinuing blood pressure medication or return of infection caused by stopping antibiotic therapy too soon. The two most common broad categories of ADE are medication errors and ADRs. A medication error is a preventable situation in which there is a compromise in the “Six Rights” of medication use: right drug, right dose, right time, right route, right patient, and right documentation. Medication errors are more common than ADRs. Medication errors occur during the prescribing, dispensing, administering, or monitoring of drug therapy. These four phases are collectively known as the medication use process. See Chapter 5 for further discussion of medication errors. An adverse drug reaction (ADR) is any reaction to a drug that is 175 unexpected and undesirable and occurs at therapeutic drug dosages. ADRs may or may not be caused by medication errors. ADRs may result in hospital admission, prolongation of hospital stay, change in drug therapy, initiation of supportive treatment, or complication of a patient's disease state. ADRs are caused by processes inside the patient's body. They may or may not be preventable, depending on the situation. Mild ADRs usually do not require a change in the patient's drug therapy or other interventions. More severe ADRs, however, are likely to require changes to a patient's drug regimen. Severe ADRs can be permanently or significantly disabling, life threatening, or fatal. They may require or prolong hospitalization, lead to organ damage (e.g., to the liver, kidneys, bone marrow, skin), cause congenital anomalies, or require specific interventions to prevent permanent impairment or tissue damage. ADRs that are specific to particular drug groups are discussed in the corresponding drug chapters in this book. Four general categories are discussed here: pharmacologic reaction, hypersensitivity (allergic) reaction, idiosyncratic reaction, and drug interaction. A pharmacologic reaction is an extension of the drug's normal effects in the body. For example, a drug that is used to lower blood pressure in a patient causes a pharmacologic ADR when it lowers the blood pressure to the point at which the patient becomes unconscious. Pharmacologic reactions that result in adverse effects are predictable, well known, and result in minor or no changes in patient management. They are related to dose and usually resolve upon discontinuation of drug therapy. An allergic reaction (also known as a hypersensitivity reaction) involves the patient's immune system. Immune system proteins known as immunoglobulins (see Chapters 47 and 48) recognize the drug molecule, its metabolite(s), or another ingredient in a drug formulation as a dangerous foreign substance. At this point, an immune response may occur in which immunoglobulin proteins bind to the drug substance in an attempt to neutralize the drug. Various chemical mediators, such as histamine, as well as cytokines and other inflammatory substances are released during this process. This 176 response can result in reactions ranging from mild reactions such as skin erythema or mild rash to severe, even life-threatening reactions such as constriction of bronchial airways and tachycardia. It can be assumed throughout this textbook that the use of any drug is contraindicated if the patient has a known allergy to that specific drug product. Allergy information may be reported by the patient as part of his or her history, or may be observed by health care personnel during a patient encounter. In either case, every effort must be made to document as fully as possible the name of the drug product and the degree and details of the adverse reaction that occurred—for example, “Penicillin; skin rash, pruritus” or “Penicillin; urticaria and anaphylactic shock requiring emergency intervention.” In more extreme cases of disease or injury (e.g., cancer, snakebite), it may be reasonable to administer a given drug in spite of a reported allergic or other adverse reaction. In such cases, the patient will likely be premedicated with additional medications as an attempt to control any adverse reactions that may occur. An idiosyncratic reaction is not the result of a known pharmacologic property of a drug or of a patient allergy, but instead occurs unexpectedly in a particular patient. Such a reaction is a genetically determined abnormal response to normal dosages of a drug. The study of such traits, which are solely revealed by drug administration, is called pharmacogenomics (see Chapter 8). Idiosyncratic drug reactions are usually caused by a deficiency or excess of drug-metabolizing enzymes. An example is glucose-6phosphate dehydrogenase (G6PD) deficiency (see the PatientCentered Care: Cultural Implications box). The final type of ADR is due to drug interactions. A drug interaction occurs when the presence of two (or more) drugs in the body produces an unwanted effect. This unwanted effect can result when one drug either enhances or reduces the effects of another drug. Some drug interactions are intentional and beneficial (see Table 2.10). However, most clinically significant drug interactions are harmful. Drug interactions specific to particular drugs are discussed in detail in the chapters dealing with those drugs. 177 Patient-Centered Care: Cultural Implications Glucose-6-Phosphate Dehydrogenase Deficiency Glucose-6-phosphate dehydrogenase (G6PD) is an enzyme found in abundant amounts in the tissues of most individuals. It reduces the risk for hemolysis of red blood cells when they are exposed to oxidizing drugs such as aspirin. The deficit is sex-linked with the structure of G-6-PD and is carried on the X chromosome. It is transmitted from mother (a healthy carrier) to a son (or daughter who would then also be a healthy carrier). This abnormality is most prevalent in Africa, affecting almost 20% of the population, but is also found in the Mediterranean (4% to 30%) and in Southeast Asia. Approximately 14% of Sardinians and more than 50% of the Kurdish Jewish population also show G6PD deficiencies. When exposed to drugs such as sulfonamides, antimalarials, and aspirin, patients with this deficiency may suffer life-threatening hemolysis of the red blood cells, whereas individuals with adequate quantities of the enzyme have no problems in taking these drugs. Other Drug Effects Other drug-related effects that must be considered during drug therapy are teratogenic, mutagenic, and carcinogenic effects. These can result in devastating patient outcomes and may be prevented in many instances by appropriate monitoring. Teratogenic effects of drugs or other chemicals result in structural defects in the fetus. Compounds that produce such effects are called teratogens. Prenatal development involves a delicate program of interrelated embryologic events. Any significant disruption in this process of embryogenesis can have a teratogenic effect. Drugs that are capable of crossing the placenta can cause drug-induced teratogenesis. Drugs administered during pregnancy can produce different types of congenital anomalies. The period during which the fetus is most vulnerable to teratogenic effects begins with the third week of development and usually ends after the third month. Chapter 3 describes the FDA safety classification for drugs used by 178 pregnant women. Mutagenic effects are permanent changes in the genetic composition of living organisms and consist of alterations in chromosome structure, the number of chromosomes, or the genetic code of the deoxyribonucleic acid (DNA) molecule. Drugs that are capable of inducing mutations are called mutagens. Radiation, viruses, chemicals (e.g., industrial chemicals such as benzene), and drugs can all act as mutagenic agents in humans. Drugs that affect genetic processes are active primarily during cell reproduction (mitosis). Carcinogenic effects are the cancer-causing effects of drugs, other chemicals, radiation, and viruses. Agents that produce such effects are called carcinogens. Some exogenous causes of cancer are listed in Box 2.3. Box 2.3 Exogenous Causes of Cancer Dietary customs Drug abuse Carcinogenic drugs Workplace chemicals Radiation Environmental pollution Food-processing procedures Food-production procedures Oncogenic viruses Smoking Pharmacognosy The source of all early drugs was nature, and the study of these natural drug sources (plants and animals) is called pharmacognosy. Although many drugs in current use are synthetically derived, most were first isolated in nature. The four main sources for drugs are plants, animals, minerals, and laboratory synthesis. Plants provide 179 many weak acids and weak bases (alkaloids) that are useful and potent drugs. Animals are the source of many hormone drugs. Conjugated estrogens are derived from the urine of pregnant mares —hence the drug trade name Premarin. Equine is the term used for any horse-derived drug. Insulin comes from two sources: pigs (porcine) and humans. Human insulin is now far more commonly used than animal insulins, thanks to the use of recombinant DNA techniques. Heparin is another commonly used drug that is derived from pigs (porcine heparin). Some common mineral sources of currently used drugs are salicylic acid, aluminum hydroxide, and sodium chloride. Pharmacoeconomics Pharmacoeconomics is the study of the economic factors influencing the cost of drug therapy. One example is performing a cost-benefit analysis of one antibiotic versus another when competing drugs are considered for inclusion in a hospital formulary. Such studies typically examine treatment outcomes data (e.g., how many patients recovered and how soon) in relation to the comparative total costs of treatment with the drugs in question. Toxicology The study of poisons and unwanted responses to both drugs and other chemicals is known as toxicology. Toxicology is the science of the adverse effects of chemicals on living organisms. Clinical toxicology deals specifically with the care of the poisoned patient. Poisoning can result from a variety of causes, ranging from drug overdose to ingestion of household cleaning agents to snakebite. Poison control centers are health care institutions equipped with sufficient personnel and information resources to recommend appropriate treatment for the poisoned patient. Effective treatment of the poisoned patient is based on a system of priorities, the first of which is to preserve the patient's vital functions by maintaining the airway, ventilation, and circulation. The second priority is to prevent absorption of the toxic substance and/or speed its elimination from the body using one or more of the 180 variety of clinical methods available. Several common poisons and their specific antidotes are listed in Table 2.11. TABLE 2.11 Common Poisons and Their Antidotes Substance Acetaminophen Organophosphates (e.g., insecticides) Tricyclic antidepressants, quinidine Calcium channel blockers Iron salts Digoxin and other cardiac glycosides Ethylene glycol (e.g., automotive antifreeze solution), methanol Benzodiazepines Beta blockers Opiates, opioid drugs Carbon monoxide (by inhalation) Antidote Acetylcysteine Atropine Sodium bicarbonate Intravenous calcium Deferoxamine Digoxin antibodies Ethanol (same as alcohol used for drinking), given intravenously Flumazenil Glucagon Naloxone Oxygen (at high concentration), known as bariatric therapy These and other antidotes are discussed throughout this textbook where applicable. Summary A thorough understanding of the pharmacologic principles of pharmacokinetics, pharmacodynamics, pharmacotherapeutics, and toxicology is essential in drug therapy and to safe, quality nursing practice. Application of pharmacologic principles enables the nurse to provide safe and effective drug therapy while always acting on behalf of the patient and respecting the patient's rights. Nursing considerations associated with various routes of drug administration are summarized in Table 2.3. Key Points • The following definitions related to drug therapy are important to remember: pharmacology 181 —the study or science of drugs; pharmacokinetics —the study of drug distribution among various body compartments after a drug has entered the body, including the phases of absorption, distribution, metabolism, and excretion; pharmaceutics—the science of dosage form design. • The nurse's role in drug therapy and the nursing process is more than just the memorization of the names of drugs, their uses, and associated interventions. It involves a thorough comprehension of all aspects of pharmaceutics, pharmacokinetics, and pharmacodynamics and the sound application of this drug knowledge to a variety of clinical situations. See Chapter 1 for further discussion of drug therapy as it relates to the nursing process. • Drug actions are related to the pharmacologic, pharmaceutical, pharmacokinetic, and pharmacodynamic properties of a given medication, and each of these has a specific influence on the overall effects produced by the drug in a patient. • Selection of the route of administration is based on patient variables and the specific characteristics of a drug. • Nursing considerations vary depending on the drug as well as the route of administration. Critical Thinking Exercises 1. Mr. L. is admitted to the trauma unit with multisystem 182 injuries from an automobile accident. He arrived at the unit with multiple abnormal findings, including shock from blood loss, decreased cardiac output, and urinary output of less than 30 mL/h. Which route of administration would you expect to be the best choice for this patient? Explain your answer. 2. You are administering medications to a patient who had an enteral tube inserted 2 days earlier for continuous feedings. As you review the medication list, you note that one drug is an enteric-coated tablet ordered to be given twice a day. What is the best action regarding giving this drug to this patient? Review Questions 1. An elderly woman took a prescription medicine to help her to sleep; however, she felt restless all night and did not sleep at all. The nurse recognizes that this woman has experienced which type of reaction or effect? a. Allergic reaction b. Idiosyncratic reaction c. Mutagenic effect d. Synergistic effect 2. The nurse is caring for a patient with cirrhosis or hepatitis, and recognizes that abnormalities in which phase of pharmacokinetics may occur in this patient? a. Absorption b. Distribution c. Metabolism d. Excretion 3. A patient who has hypertension is now taking a daily 183 beta blocker. Which term best describes this type of therapy? a. Palliative therapy b. Maintenance therapy c. Supportive therapy d. Supplemental therapy 4. The nurse is giving medications to a patient in heart failure. The intravenous route is chosen instead of the intramuscular route. What physical function does the nurse recognize as the most influential when deciding to use the intravenous route of drug administration? a. Altered biliary function b. Increased glomerular filtration c. Reduced liver metabolism d. Diminished circulation 5. A patient has just received a prescription for an entericcoated stool softener. When teaching the patient, the nurse should include which statements? (Select all that apply.) a. “Take the tablet with 2 to 3 ounces of orange juice.” b. “Be sure to drink 6 to 8 ounces of water with this tablet.” c. “Avoid taking all other medications with any entericcoated tablet.” d. “Crush the tablet before swallowing if you have problems with swallowing.” e. “Be sure to swallow the tablet whole without chewing it.” 6. Each statement describes a phase of pharmacokinetics. Put the statements in order, with 1 indicating the phase 184 that occurs first and 4 indicating the phase that occurs last. a. Enzymes in the liver transform the drug into an inactive metabolite. b. Drug metabolites are secreted through passive glomerular filtration into the renal tubules. c. A drug binds to the plasma protein albumin and circulates through the body. d. A drug moves from the intestinal lumen into the mesenteric blood system. 7. A drug that delivers 300 mg has a half-life of 4 hours. How many milligrams of drug will remain in the body after 1 half-life? 8. The nurse is reviewing the various forms of topical medications. Which of these are considered topical medications? (Select all that apply.) a. Rectal ointment for hemorrhoids b. Eye drops for inflammation c. Sublingual tablet for chest pain d. Inhaled medication for asthma e. Intradermal injection for tuberculosis testing References Center to Advance Palliative Care. What is palliative care?. [Available at] www.getpalliativecare.org/whatis/faq. Konig JT, Muller F, Fromm M. Transporters and drug-drug interactions: important determinants of drug disposition and effects. Pharmacological Reviews. 2013;65(3):944–966. 185 Kids Health from Nemours. G6PD deficiency. [Available at] http://kidshealth.org/en/parents/g6pd.html. Luzzatto L, Seneca E. G6PD deficiency: a classic example of pharmacogenetics with on-going clinical implications. British Journal of Haematology. 2013;64(4):469–480. US Food and Drug Administration. Avoiding drug interactions. [Available at] www.fda.gov/forconsumers/consumerupdates/ucm096386.h US Food and Drug Administration. Drug interactions: what you should know. [Available at] www.fda.gov/drugs/resourcesforyou/ucm163354.htm Voelker R. News from the Food and Drug Administration. JAMA: The Journal of the American Medical Association. 2016;315(19):2057. Wessper JD, Grip LT, et al. The P-glycoprotein transport system and cardiovascular drugs. Journal of the American College of Cardiology. 2013;61(25):2495–2502. 186 3 Lifespan Considerations OBJECTIVES When you reach the end of this chapter, you will be able to do the following: 1. Discuss the influences of the patient's age on the effects of drugs and drug responses. 2. Identify drug-related concerns during pregnancy and lactation and provide an explanation of the physiologic basis for these concerns. 3. Summarize the impact of age-related physiologic changes on the pharmacokinetic aspects of drug therapy. 4. Explain how these age-related changes in pharmacokinetics influence various drug effects and drug responses across the lifespan. 5. Provide several examples of how age affects the absorption, distribution, metabolism, and excretion of drugs. 6. Calculate a drug dose for a pediatric patient using the various formulas available. 7. Develop a nursing care plan for drug therapy and the nursing process as related to the various lifespan considerations. 187 KEY TERMS Active transport The active (energy-requiring) movement of a substance between different tissues via pumping mechanisms contained within cell membranes. Diffusion The passive movement of a substance (e.g., a drug) between different tissues from areas of higher concentration to areas of lower concentration. (Compare with active transport.) Neonate Pertaining to a person younger than 1 month of age; newborn infant. Older adult Pertaining to a person who is 65 years of age or older. (Note: Some sources consider “older adult” to be 55 years of age or older.) Pediatric Pertaining to a person who is 12 years of age or younger. Polypharmacy The use of many different drugs concurrently in treating a patient, who often has several health problems. Overview From the beginning to the end of life, the human body changes in many ways. These changes have dramatic effects on the four phases of pharmacokinetics—drug absorption, distribution, metabolism, and excretion. Newborn, pediatric, and older adult patients each have special needs. Drug therapy at both spectrums of life is more likely to result in adverse effects and toxicity. Fortunately, response to drug therapy changes in a predictable manner in younger and older patients. Knowing the effect that age has on the pharmacokinetic characteristics of drugs helps predict these changes. Most experience with drugs and pharmacology has been gained from the adult population. The majority of drug studies have focused on the population between 13 and 65 years of age. It has been estimated that 75% of currently approved drugs lack US Food and Drug Administration (FDA) approval for pediatric use and therefore lack specific dosage guidelines for neonates and children. 188 Fortunately, many excellent pediatric drug dosage books are available. Most drugs are effective in younger and older patients, but drugs behave very differently in patients at the opposite ends of the age spectrum. It is vitally important from the standpoint of safe and effective drug administration to understand what these differences are and how to adjust for them. Drug Therapy During Pregnancy A fetus is exposed to many of the same substances as the mother, including any drugs that she takes—prescription, nonprescription, or street drugs. The first trimester of pregnancy is generally the period of greatest danger of drug-induced developmental defects. Transfer of both drugs and nutrients to the fetus occurs primarily by diffusion across the placenta, although not all drugs cross the placenta. Diffusion is a passive process based on differences in concentration between different tissues. Active transport requires the expenditure of energy and often involves some sort of cellsurface protein pump. The factors that contribute to the safety or potential harm of drug therapy during pregnancy can be broadly broken down into three areas: drug properties, fetal gestational age, and maternal factors. Drug properties that impact drug transfer to the fetus include the drug's chemistry, dosage, and concurrently administered drugs. Examples of relevant chemical properties include molecular weight, protein binding, lipid solubility, and chemical structure. Important drug dosage variables include dose and duration of therapy. Fetal gestational age is an important factor in determining the potential for harmful drug effects to the fetus. The fetus is at greatest risk for drug-induced developmental defects during the first trimester of pregnancy. During this period, the fetus undergoes rapid cell proliferation. Skeleton, muscles, limbs, and visceral organs are developing at their most rapid rate. Self-treatment of minor illness is strongly discouraged anytime during pregnancy, but especially during the first trimester. Gestational age is also important in determining when a drug can most easily cross the placenta to the fetus. During the last trimester, the greatest percentage of maternally absorbed drug gets to the fetus. 189 Maternal factors also play a role in determining drug effects on the fetus. Any change in the mother's physiology can affect the amount of drug to which the fetus may be exposed. Maternal kidney and liver function affect drug metabolism and excretion. Impairment in either kidney or liver function may result in higher drug levels and/or prolonged drug exposure, and thus increased fetal transfer. Maternal genotype may also affect how certain drugs are metabolized (pharmacogenomics). The lack of certain enzyme systems may result in adverse drug effects to the fetus when the mother is exposed to a drug that is normally metabolized by the given enzyme. Although exposure of the fetus to drugs is most detrimental during the first trimester, drug transfer to the fetus is more likely during the last trimester. This is the result of enhanced blood flow to the fetus, increased fetal surface area, and increased amount of free drug in the mother's circulation. It is important to use drugs judiciously during pregnancy; however, there are certain situations that require their use. Without drug therapy, maternal conditions such as hypertension, epilepsy, diabetes, and infection could seriously endanger both the mother and the fetus, and the potential for harm far outweighs the risks of appropriate drug therapy. The FDA classifies drugs according to their safety for use during pregnancy. This system of drug classification is based primarily on animal studies and limited human studies. This is due in part to ethical dilemmas surrounding the study of potential adverse effects on fetuses. Traditionally, the most widely used index of potential fetal risk of drugs has been the FDA's pregnancy safety category system. The five safety categories are described in Table 3.1. The FDA is requiring new pregnancy labeling to be included in their respective package inserts for all newly approved drugs and allowing currently marketed drugs to be phased in gradually. It is anticipated that these new changes will not be fully in effect for several years. The student will likely encounter both the old categories (A to X) as well as the new rules throughout his or her career. The new rule requires the use of three subsections in the prescribing information titled “Pregnancy,” “Lactation,” and “Females and Males of Reproductive Potential.” These subsections 190 will include a summary of the risks of using a drug during pregnancy and breastfeeding, as well as data supporting the summary and information to help health care providers make prescribing decisions. The “Pregnancy” section will include information on dosing and potential risks to the developing fetus. The “Lactation” section will provide information regarding breastfeeding, such as the amount of drug in breast milk and the potential effect on the child. The “Females and Males of Reproductive Potential” section will include information about contraception, pregnancy testing, and infertility. Because not all drugs on the market have the new information, this book will continue to use the letter categories, and the reader is referred to individual drug package inserts for the newest information. TABLE 3.1 Pregnancy, Lactation, and Reproduction Category Category A Description Studies indicate no risk to the human fetus. Studies indicate no risk to the animal fetus; information for humans is not available. Adverse effects reported in the animal fetus; information for humans is not available. Possible fetal risk in humans has been reported; however, in selected cases consideration of the potential benefit versus risk may warrant use of these drugs in pregnant women. Fetal abnormalities have been reported, and positive evidence of fetal risk in humans is available from animal and/or human studies. These drugs are not to be used in pregnant Category B Category C Category D Category X 191 New FDA rules, effective June 2015, for newly approved drugs: Drugs currently on the market are allowed to be phased in. This information will replace the A to X categories. Not all drugs have phased in the new information and this textbook will continue to use the letters. The student is referred to individual drug package inserts for the newest information. women. Three detailed subsections on “Pregnancy,” “Lactation,” and “Females and Males of Reproductive Potential” FDA, US Food and Drug Administration. Drug Therapy During Breastfeeding Breastfed infants are at risk for exposure to drugs consumed by the mother. A wide variety of drugs easily cross from the mother's circulation into the breast milk and subsequently to the breastfeeding infant. Drug properties similar to those discussed in the previous section influence the exposure of infants to drugs via breastfeeding. The primary drug characteristics that increase the likelihood of drug transfer via breastfeeding include fat solubility, low molecular weight, and high concentration. Fortunately, breast milk is not the primary route for maternal drug excretion. Drug levels in breast milk are usually lower than those in the maternal circulation. The actual amount of exposure depends largely on the volume of milk consumed. The ultimate decision as to whether a breastfeeding mother takes a particular drug depends on the risk/benefit ratio. The risks of drug transfer to the infant in relation to the benefits of continuing breastfeeding and the therapeutic benefits to the mother must be considered on a caseby-case basis. Considerations for Neonatal and Pediatric Patients Pediatric patients are defined based on age. A neonate is defined as between birth and 1 month of age. An infant is between 1 and 12 months of age, and a child is between 1 and 12 years of age. The age ranges that correspond to the various terms applied to pediatric patients are shown in Table 3.2. 192 TABLE 3.2 Classification of Young Patients Age Range Younger than 38 weeks' gestation Younger than 1 month 1 month up to 1 year 1 year up to 12 years Classification Premature or preterm infant Neonate or newborn infant Infant Child NOTE: The meaning of the term pediatric may vary with the individual drug and clinical situation. Often the maximum age for a pediatric patient may be identified as 16 years of age. Consult the manufacturer's guidelines for specific dosing information. Physiology and Pharmacokinetics Pediatric patients handle drugs much differently than adult patients, based primarily on the immaturity of vital organs. In both neonates and older pediatric patients, anatomic structures and physiologic systems and functions are still in the process of developing. The Patient-Centered Care: Lifespan Considerations for the Pediatric Patient box on this page lists those physiologic factors that alter the pharmacokinetic properties of drugs in young patients. Pharmacodynamics Drug actions (or pharmacodynamics) are altered in young patients, and the maturity of various organs determines how drugs act in the body. Certain drugs may be more toxic, whereas others may be less toxic. The sensitivity of receptor sites may also vary with age; thus higher or lower dosages may be required depending on the drug. In addition, rapidly developing tissues may be more sensitive to certain drugs, and therefore smaller dosages may be required. Certain drugs are contraindicated during the growth years. For instance, tetracycline may permanently discolor a young person's teeth; corticosteroids may suppress growth when given systemically (but not when delivered via asthma inhalers, for example); and quinolone antibiotics may damage cartilage. 193 Patient-Centered Care: Lifespan Considerations for the Pediatric Patient Pharmacokinetic Changes in the Neonate and Pediatric Patient Absorption • Gastric pH is less acidic because acid-producing cells in the stomach are immature until approximately 1 to 2 years of age. • Gastric emptying is slowed because of slow or irregular peristalsis. • First-pass elimination by the liver is reduced because of the immaturity of the liver and reduced levels of microsomal enzymes. • Intramuscular absorption is faster and irregular. Distribution • Total body water is 70% to 80% in full-term infants, 85% in premature newborns, and 64% in children 1 to 12 years of age. • Fat content is lower in young patients because of greater total body water. • Protein binding is decreased because of decreased production of protein by the immature liver. • More drugs enter the brain because of an immature bloodbrain barrier. Metabolism • Levels of microsomal enzymes are decreased because the immature liver has not yet started producing enough. • Older children may have increased metabolism and require higher dosages once hepatic enzymes are produced. • Many variables affect metabolism in premature infants, infants, 194 and children, including the status of liver enzyme production, genetic differences, and substances to which the mother was exposed during pregnancy. Excretion • Glomerular filtration rate and tubular secretion and resorption are all decreased in young patients because of kidney immaturity. • Perfusion to the kidneys may be decreased, which results in reduced renal function, concentrating ability, and excretion of drugs. Dosage Calculations for Pediatric Patients Most drugs have not been sufficiently investigated to ensure their safety and effectiveness in children. In spite of this, there are numerous excellent pediatric dosage references. Because pediatric patients (especially premature infants and neonates) have small bodies and immature organs, they are very susceptible to drug interactions, toxicity, and unusual drug responses. Pediatric patients require different dosage calculations than do adults. Characteristics of pediatric patients that have a significant effect on dosage include the following: • Skin is thinner and more permeable. • Stomach lacks acid to kill bacteria. • Lungs have weaker mucous barriers. • Body temperature is less well regulated, and dehydration occurs easily. • Liver and kidneys are immature, and therefore drug metabolism and excretion are impaired. Many formulas for pediatric dosage calculation have been used throughout the years. Calculating the dosage according to the body weight is the most commonly used method today. Most drug 195 references recommend dosages based on milligrams per kilogram of body weight. The following information is needed to calculate the pediatric dosage: • Drug order (as discussed previously) • Pediatric patient's weight in kilograms (1 kg = 2.2 pounds) (e.g., a 10-lb baby weighs 4.5 kg; divide the number of pounds by 2.2 to determine kilograms) • Pediatric dosage as per manufacturer or drug formulary guidelines, and • Information regarding available dosage forms When using either of the previous methods, the following must be done to ensure the correct pediatric dose: • Determine the pediatric patient's weight in kilograms. • Use a current drug reference to determine the usual dosage range per 24 hours in milligrams (mg) per kilogram (kg). It must be noted that some drugs are stated as mg/kg per dose. • Determine the dose parameters by multiplying the weight by the minimum and maximum daily doses of the drug (the safe range). • Determine the total amount of the drug to administer per dose and per day. • Compare the drug dosage prescribed with the calculated safe range. • If the drug dosage raises any concerns or varies from the safe range, contact the health care provider or prescriber immediately and do not 196 give the drug! A common source of medication error and potential toxicity is confusing pounds with kilograms. Unless otherwise noted, the child's weight is to be given in kilograms, not pounds. Take great care to ensure that the correct weight is reported to the prescriber. In calculating pediatric dosages, the factor of organ maturity must always be considered along with age, and weight. When all of these physical developmental factors are considered and doses are calculated correctly, the likelihood of safe and effective drug administration is increased. Emotional developmental considerations must also be a part of the decision-making process in drug therapy for pediatric patients (see the Patient-Centered Care: Lifespan Considerations for the Pediatric Patient box on this page). Patient-Centered Care: Lifespan Considerations for the Pediatric Patient Age-Related Considerations for Safety in Medication Administration From Infancy to Adolescence General Interventions • Always come prepared for the procedure (e.g., prepare for injections with filter needles for ampules, blunt tip needles for vials and/or proper gauge/length needle, and gather all needed equipment). • Ask the parent and/or child (if age-appropriate) if the parent will remain for the procedure (for in-hospital administration). • Assess for comfort methods that are appropriate before and after drug administration. Infants • While maintaining safe and secure positioning of the infant (e.g., with parent holding, rocking, cuddling, soothing), 197 perform the procedure (e.g., injection) swiftly and safely. • Allow self-comforting measures as age-appropriate (e.g., use of pacifier, fingers in mouth, self-movement). Toddlers • Offer a brief, concrete explanation of the procedure, but with realistic expectations of the child's actual understanding of the information. Parents, caregivers, or other legal guardians must be part of the process. Hold the child securely while administering the medication. • Accept aggressive behavior as a healthy response, but only within reasonable limits. • Provide comfort measures immediately after the procedure (e.g., touching, holding). • Help the child understand the treatment and his or her feelings through puppet play or play with stuffed animals or hospital equipment such as empty, needleless syringes. • Provide for healthy ways to release aggression such as ageappropriate supervised playtime. Preschoolers • Offer a brief, concrete explanation of the procedure at the patient's level and with the parent or caregiver present. • Provide comfort measures after the procedure (e.g., touching, holding). • Identify and accept aggressive responses, and provide ageappropriate outlets. • Make use of magical thinking (e.g., using ointments or “special medicines” to make discomfort go away). • Note that the role of the parent in providing comfort and understanding is very important. School-Age Children 198 • Explain the procedure, allowing for some control over body and situation. • Provide comfort measures. • Explore feelings and concepts through the use of therapeutic play. Art may be used to help the patient express fears. Use of age-appropriate books and realistic hospital equipment may also be helpful. • Set age-appropriate behavior limits (e.g., okay to cry or scream, but not to bite). • Provide age-appropriate activities for releasing aggression and anger. • Use the opportunity to teach about the relationship between receiving medication and body function and structure (e.g., what a seizure is and how medication helps prevent the seizure). • Offer the complete picture (e.g., need to take medication, relax with deep breaths; medication will help prevent pain). Adolescents • Prepare the patient in advance for the procedure but without scare tactics. • Allow for expression in a way that does not cause losing face, such as giving the adolescent time alone after the procedure (e.g., once a seizure is controlled) and giving the adolescent time to discuss his or her feelings. • Explore with the adolescent any current concepts of self, hospitalization, and illness, and correct any misconceptions. • Encourage self-expression, individuality, and self-care. • Encourage participation in procedures as appropriate. Hockenberry, M., & Wilson, D. (2016). Wong's nursing care of infants and children (10th ed.). St. Louis: Elsevier Mosby; and The Safer Health Care for Kids Program. Available at www.aap.org/saferhealthcare. Accessed April 30, 2015. 199 Considerations for Older Adult Patients Due to the decline in organ function that occurs with advancing age, older adult patients handle drugs physiologically differently than younger adult patients. Drug therapy in the older adult is more likely to result in adverse effects and toxicity. In this textbook, the word older adult is used instead of the word geriatric or elderly; however, these terms are synonymous. An older adult patient is defined as a person who is 65 years of age or older. This segment of the population is growing at a dramatic pace (see the PatientCentered Care: Lifespan Considerations for the Older Adult Patient box on this page). At the beginning of the twentieth century, older adults constituted a mere 4% of the total population. At that time, more people died of infections than of chronic illnesses such as heart disease, cancer, and diabetes. As medical and health care technology has advanced, so has the ability to prolong life. This has resulted in a growing population of older adults. Today patients older than 65 years of age constitute 15% of the population. Life expectancy is currently approximately 86.6 years for females and 84.3 years for men. It is estimated that 21.7% of the population will be 65 years of age or older by 2040. These trends are expected to continue as new disease prevention and treatment methods are developed. Patient-Centered Care: Lifespan Considerations for the Older Adult Patient Percentage of Population Older Than Age 65 Year 1900 2000 2040 Percentage Older Than Age 65 4 12 21.7 Issues in Clinical Drug Use in the Older Adult 200 The older adult population consumes a larger proportion of all medications than other population groups. A recent survey of people aged 62 to 85 showed that at least one prescription medication was used by 87%, while 36% of older adults used five or more medications and 38% used over-the-counter medications (Qato, Wilder, Schumm, et al, 2016). Taking multiple medications and over-the-counter drugs increases the risk for drug interactions. Commonly prescribed drugs for older adults include antihypertensives, beta blockers, diuretics, insulin, and potassium supplements. The most commonly used over-the-counter drugs are analgesics, laxatives, and nonsteroidal antiinflammatory drugs (NSAIDs). Older adults, especially those of certain ethnicities, may use various folk remedies of unknown composition that are unfamiliar to their health care providers. Not only do older adult patients consume a greater proportion of prescription and over-the-counter medications; they commonly take multiple medications on a daily basis. One reason for the use of multiple medications is the more frequent occurrence of chronic diseases and the multiple drug options available for treatment. More complicated medication regimens predispose older adults to self-medication errors, especially those with reduced visual acuity and manual dexterity. Such sensory and motor deficits can be particularly problematic when older adult patients split their own tablets. The practice of pill splitting occurs commonly for financial reasons, because lower- and higher-strength tablets often have similar costs. Furthermore, some insurance companies require tablet splitting for this reason. Other factors that may contribute to medication errors include lack of adequate patient education and understanding of their drug regimens, and use of multiple prescribers and multiple pharmacies. In this age of medical specialization, patients may see several prescribers for their many illnesses. Because of this, it is very important for the patient to use only one pharmacy so that monitoring for drug interactions and duplicate therapy can occur. Older adult patients are hospitalized frequently due to adverse drug reactions (ADRs). Many people use complementary and alternative medicines such as herbal remedies and dietary supplements, which can interact with prescription drugs. The 201 simultaneous use of multiple medications is called polypharmacy. As the number of medications a person takes increases, so does the risk for drug interaction and ADRs. Some drugs may be given specifically to counteract the adverse effects of other drugs (e.g., a potassium supplement to counteract the potassium loss caused by certain diuretic medications), which is one example of what is known as the prescribing cascade. Sometimes it is difficult to distinguish adverse drug effects from disease symptoms. Although such prescribing is sometimes appropriate, it also increases the potential for more adverse drug events (including drug interactions, hospitalization or prolonged hospital stays, hip fractures secondary to drug-induced falls, addiction risk, anorexia, confusion, urinary retention, and fatigue). Recognizing polypharmacy and taking steps to reduce it whenever possible by decreasing the number and/or dosages of drugs taken can significantly reduce the incidence of adverse outcomes. Appropriate drug doses for older adults may sometimes be one-half to two-thirds of the standard adult dose. As a general rule, dosing for the older adult should follow the admonition “Start low and go slow,” which means to start with the lowest possible dose (often less than an average adult dose) and increase the dose slowly, based on patient response. Another important issue is noncompliance, or nonadherence, with prescribed medication regimens. Drug nonadherence is reported to occur in roughly 55% of older adult patients and is associated with increased rates of hospitalization. Some patients want to adhere to their medication regimen but truly cannot afford the medicine. Patients in this situation need to be referred to a health care social worker or their prescriber. Many drug companies offer patient assistance for expensive medications. Physiologic Changes Physiologic changes associated with aging affect the action of many drugs. As the body ages, functioning of several organ systems slowly decline. The collective physiologic changes associated with the aging process have a major effect on the disposition and action of drugs. Table 3.3 lists some of the body systems most affected by 202 the aging process. TABLE 3.3 Physiologic Changes in the Older Adult Patient System Cardiovascular Gastrointestinal Hepatic Renal Physiologic Change ↓ Cardiac output = ↓ absorption and distribution ↓ Blood flow = ↓ absorption and distribution ↑ pH (alkaline gastric secretions) = altered absorption ↓ Peristalsis = delayed gastric emptying ↓ Enzyme production = ↓ metabolism ↓ Blood flow = ↓ metabolism ↓ Blood flow = ↓ excretion ↓ Function = ↓ excretion ↓ Glomerular filtration rate = ↓ excretion The sensitivity of the older adult to many drugs requires careful monitoring and dosage adjustment. The criteria for drug dosages in older adults must include consideration of body weight and organ functioning, with emphasis on liver, renal, cardiovascular, and central nervous system function (similar to the criteria for pediatric dosages). With aging, there is a general decrease in body weight. Changes in drug molecule receptors in the body can make a patient more or less sensitive to certain medications. For example, older adults commonly have increased sensitivity to central nervous system depressant medications (e.g., anxiolytics, tricyclic antidepressants) because of reduced integrity of the blood-brain barrier. It is important to monitor the results of laboratory tests, as these values serve as a gauge of organ function. The most important organs from the standpoint of the breakdown and elimination of drugs are the liver and the kidneys. Kidney function is assessed by measuring serum creatinine and blood urea nitrogen levels. Creatinine is a by-product of muscle metabolism. Because muscle mass declines with age, serum creatinine level may provide a misleading index of renal function. For example, a frail older female may have a reported serum creatinine value that is lower than normal, and this may lead one to falsely think that her renal function is normal. In actuality, because this patient has limited muscle mass, she cannot produce creatinine. The seasoned clinician 203 knows that renal function declines with age and that this value alone does not give an accurate estimate of renal function. The most accurate way to determine creatinine clearance is by collecting a patient's urine for 24 hours. This test is quite cumbersome, however, and is not used very often. Fortunately, several equations exist that allow pharmacists and prescribers to accurately assess renal function. Frequency of testing for renal function is often dictated by the degree of renal dysfunction and the type of medications being prescribed or used. Liver function is assessed by testing the blood for liver enzymes such as aspartate aminotransferase (AST) and alanine aminotransferase (ALT). These laboratory values can help in assessing the ability to metabolize and eliminate medications and can aid in anticipating the risk for toxicity and/or drug accumulation. Laboratory assessments need to be conducted at least annually, both for preventive health monitoring and for screening for possible toxic effects of drug therapy. Such assessments may be indicated more frequently (e.g., every 1, 3, or 6 months) in those patients requiring higher-risk drug regimens. Pharmacokinetics The pharmacokinetic phases of absorption, distribution, metabolism, and excretion (see Chapter 2) may be different in the older adult than in the younger adult. Awareness of these differences helps ensure appropriate administration of drugs and monitoring. The Patient-Centered Care: Lifespan Considerations for the Older Adult Patient box on this page lists the four pharmacokinetic phases and summarizes how they are altered by the aging process. Patient-Centered Care: Lifespan Considerations for the Older Adult Patient Pharmacokinetic Changes Absorption 204 • Gastric pH is less acidic because of a gradual reduction in the production of hydrochloric acid in the stomach. • Gastric emptying is slowed because of a decline in smooth muscle tone and motor activity. • Movement throughout the gastrointestinal (GI) tract is slower because of decreased muscle tone and motor activity. • Blood flow to the GI tract is reduced by 40% to 50% because of decreased cardiac output and decreased perfusion. • The absorptive surface area is decreased because the aging process blunts and flattens villi. Distribution • In adults 40 to 60 years of age, total body water is 55% in males and 47% in females; in those older than 60 years of age, total body water is 52% in males and 46% in females. • Decrease in total body water leads to decreased distribution of some drugs, such as antibiotics, leading to risk of toxicity because of greater concentrations of drug in the blood stream. • Fat content is increased because of decreased lean body mass. • Protein (albumin) binding sites are reduced because of decreased production of proteins by the aging liver and reduced protein intake leading to greater amounts of free drug. Metabolism • The levels of microsomal enzymes are decreased because the capacity of the aging liver to produce them is reduced. • Liver blood flow is reduced by approximately 1.5% per year after 25 years of age, which decreases hepatic metabolism. • Decreased metabolism leads to potential for drug toxicity. Excretion • Glomerular filtration rate is decreased by 40% to 50%, primarily because of decreased blood flow. 205 • The number of intact nephrons is decreased. • Drugs are cleared less effectively because of decreased excretion. • Creatinine clearance is an important indicator of renal functioning and therefore, if abnormal, drug dosages may need to be adjusted by the prescriber. Absorption Absorption in the older person can be altered by many mechanisms. Advancing age results in reduced absorption of both dietary nutrients and drugs. Several physiologic changes account for this reduction in absorption. Older adults have a gradual reduction in the ability of the stomach to produce hydrochloric acid, which results in a decrease in gastric acidity and may alter the absorption of some drugs. In addition, the combination of decreased cardiac output and advancing atherosclerosis results in a general reduction in the flow of blood to major organs, including the stomach. By 65 years of age, there is an approximately 50% reduction in blood flow to the gastrointestinal (GI) tract. Absorption, whether of nutrient or drug, is dependent on good blood supply to the stomach and intestines. The absorptive surface area of an older adult's GI tract is often reduced, thus decreasing drug absorption. GI motility is important for moving substances out of the stomach and also for moving them throughout the GI tract. Muscle tone and motor activity in the GI tract are reduced in older adults. This often results in constipation, for which older adults frequently take laxatives. This use of laxatives may accelerate GI motility enough to actually reduce the absorption of drugs. Distribution The distribution of medications throughout the body is also different in older adults. There seems to be a gradual reduction in the total body water content with aging. Therefore the concentrations of highly water-soluble (hydrophilic) drugs may be higher in older adults because they have less body water in which 206 the drugs can be diluted. The composition of the body also changes with aging, with a decrease in lean muscle mass and an increase in body fat. In both men and women, there is an approximately 20% reduction in muscle mass between 25 and 65 years of age and a corresponding 20% increase in body fat. Fat-soluble or lipophilic drugs, such as hypnotics and sedatives, are primarily distributed to fatty tissues and may result in prolonged drug actions and/or toxicity. Older adults may have reduced protein concentrations, due in large part to reduced liver function. Reduced dietary intake and/or poor GI protein absorption can cause nutritional deficiencies and reduced blood protein levels. Regardless of the cause, the result is a reduced number of protein-binding sites for highly protein-bound drugs. This results in higher levels of unbound (active) drug in the blood. Remember that only drugs not bound to proteins are active. Therefore the effects of highly protein-bound drugs may be enhanced if their dosages are not adjusted to accommodate any reduced serum albumin concentrations. Some highly protein-bound drugs include warfarin and phenytoin. Metabolism Metabolism declines with advancing age. The transformation of active drugs into inactive metabolites is primarily performed by the liver. The liver loses mass with age and slowly loses its ability to metabolize drugs effectively due to reduced production of microsomal (cytochrome P-450) enzymes. There is also a reduction in blood flow to the liver because of reduced cardiac output and atherosclerosis. A reduction in the hepatic blood flow of approximately 1.5% per year occurs after 25 years of age. All of these factors contribute to prolonging the half-life of many drugs (e.g., warfarin), which can potentially result in drug accumulation if serum drug levels are not closely monitored. Excretion Renal function declines in roughly two-thirds of older adults. A reduction in the glomerular filtration rate of 40% to 50%, combined with a reduction in cardiac output leading to reduced renal 207 perfusion, can result in delayed drug excretion and therefore drug accumulation. This is especially true for drugs with a low therapeutic index such as digoxin. Renal function needs to be monitored frequently. Appropriate dose and interval adjustments may be determined based on the results of renal and liver function studies as well as the presence of therapeutic levels of the drug in the serum. If a decrease in renal and liver function is known, adjust the dosage so that drug accumulation and toxicity may be avoided or minimized. Problematic Medications for the Older Adult Certain classes of drugs are more likely to cause problems in older adults because of many of the physiologic alterations and pharmacokinetic changes already discussed. Table 3.4 lists some of the more common medications that are problematic. Some drugs to be avoided in the older adult have been identified by various professional organizations such as the American Nurses Association, as well as by various other authoritative sources. Since the 1990s, a very effective tool, the Beers Criteria, has been used to identify drugs that may be inappropriately prescribed, ineffective, or cause adverse drug reactions in older adult patients (see the Evidence-Based Practice box). The Beers Criteria, updated again in 2015, are very useful and help determine risk-associated situations for older adults and specific drugs that may be problematic. TABLE 3.4 Medications and Conditions Requiring Special Considerations in the Older Adult Patient Medication Analgesics Opioids Nonsteroidal antiinflammatory drugs (NSAIDs) Anticoagulants (heparin, warfarin) Anticholinergics Common Complications Confusion, constipation, urinary retention, nausea, vomiting, respiratory depression, falls Edema, nausea, gastric ulceration, bleeding, renal toxicity Major and minor bleeding episodes, many drug interactions, dietary interactions Blurred vision, dry mouth, constipation, confusion, urinary retention, tachycardia 208 Antidepressants Sedation and strong anticholinergic adverse effects (see above) Antihypertensives Nausea, hypotension, diarrhea, bradycardia, heart failure, impotence Cardiac glycosides (e.g., digoxin) Visual disorders, nausea, diarrhea, dysrhythmias, hallucinations, decreased appetite, weight loss Central nervous system (CNS) Sedation, weakness, dry mouth, confusion, depressants (muscle relaxants, urinary retention, ataxia opioids) Sedatives and hypnotics Confusion, daytime sedation, ataxia, lethargy, increased risk for falls Thiazide diuretics Electrolyte imbalance, rashes, fatigue, leg cramps, dehydration Condition Drugs Requiring Special Caution and Monitoring Bladder flow obstruction Anticholinergics, antihistamines, decongestants, antidepressants Clotting disorders NSAIDs, aspirin, antiplatelet drugs Chronic constipation Calcium channel blockers, tricyclic antidepressants, anticholinergics Chronic obstructive pulmonary Long-acting sedatives or hypnotics, narcotics, disease beta blockers Heart failure and hypertension Sodium, decongestants, amphetamines, overthe-counter cold products Insomnia Decongestants, bronchodilators, monoamine oxidase inhibitors Parkinson's disease Antipsychotics, phenothiazines Syncope, falls Sedatives, hypnotics, opioids, CNS depressants, muscle relaxants, antidepressants, antihypertensives Nursing Process Assessment Before any medication is administered to a pediatric patient, obtain a health history and medication history with assistance from the parent, caregiver, or legal guardian. The following are some areas to be included: • Age • Age-related concerns about organ functioning 209 • Age-related fears • Allergies to drugs and food • Baseline values for vital signs • Head-to-toe physical assessment findings • Height in feet/inches and centimeters • Weight in kilograms and pounds • Level of growth and development and related developmental tasks Evidence-Based Practice Update on Application of the Beers Criteria for Prevention of Adverse Drug Events in Older Adults Review In 1991, a panel of experts led by Mark H. Beers, MD, identified a list of “potentially inappropriate medications” (PIM) for use in individuals 65 years of age and older. These criteria were intended for use with nursing home residents and then were expanded and revised to include all settings of geriatric care. The specific aim of the project was to predict ADRs in this age group. The Beers Criteria were updated in 1997 and 2002, and provided a listing of drugs and drug classes to be avoided in older adults. The criteria also identified disease states considered to be contraindications for some drugs. In 2005, research was conducted to confirm the relationship between PIM prescribing, as defined by Beers Criteria, and the occurrence of ADRs in older adult patients treated at outpatient clinics. In 2012, a list of medications was identified and classified into three categories: (1) potentially inappropriate medications and classes to avoid in older adults, (2) potentially inappropriate medications and classes to avoid in older adults with certain diseases and syndromes, and (3) medications to be used with caution in older adults. The 2015 update provided concerns for several lists of medications, three new drugs and two new drug 210 classes that were not covered under the previous updates. Methodology The 2015 Updated American Geriatrics Society Beers Criteria reflect tremendous efforts and work completed by a panel of 13 geriatrics experts that was convened by the American Geriatrics Society (AGS). Methods of research included hand-searches of published studies and searches of electronic databases. This panel searched for specific clinical trials and research studies since the publishing of the 2012 AGS Beers Criteria. Panel members reviewed abstracts and developed evidence tables reflecting some 342 studies including 60 systematic reviews and meta-analyses, 49 randomized controlled trials, and 233 observational as well as other types of publications. A weighting was used to assess the quality and strength of evidence. An independent researcher prepared evidence tables with a summary of the study and a quality rating and rating of the risk of bias for the articles used. Several approaches were used to rate the articles. After implementing very specific research methods and use of extensive review, a consensus of updated guidelines was reached by the expert panel members. The guidelines were then posted to relevant organizations and societies and posted on the AGS website for comment. All comments were reviewed and addressed. Findings With the 2015 update, the Beers Criteria now contain separate instructions on some 13 combination of medication to avoid that are known to cause harmful drug–drug interactions, a list of 20 medications that are deemed problematic and need to be avoided or doses to be adjusted based on renal functioning and new medications and classes of medications, including proton pump inhibitors due to association of significant consequences to one's health. Within the recommendations, there were medications used in older adults that were categorized by organ system, therapeutic category, and drug, followed by rationale for the medication and/or class to be identified as potentially inappropriate, a recommendation followed by the strength of evidence. This information is clearly identified in a table within the 2015 AGS Beers Criteria update. 211 Application to Nursing Practice These Criteria are improved and provide a much needed update for drugs to avoid and use with caution in older adults. They also increase awareness of inappropriate medication use in this age group and may also be integrated into electronic health records. Various clinical specialties benefit from this information such as family practice, geriatrics, internal medicine and pharmacology. Intended users of the Criteria include health care providers, hospitals, managed care organizations, physicians, pharmacists, public health departments, physician assistants, advanced practice nurses, nurses, and patients all over the world. It should be very clear that the major advantage is to older patients and their caregivers and with the result of decreasing the incidence of medication-related problems and adverse drug events as well as decreasing the morbidity/mortality related to medication use. These Criteria do have several limitations, including the underrepresentation of older adults in drug trials and the exclusion of studies published in other languages besides English. However, the older patient is the one with the most to gain and benefit from these and any future Beers Criteria. With the support of the AGS, the Criteria will continue to develop over time and will continue to help improve the health of older adults. Modified from American Geriatrics Society 2015 Beers Criteria Update Expert Panel. (2015). American Geriatric Society 2015 updated Beers Criteria for potentially inappropriate medication use in older adults. Journal of the American Geriatrics Society, 63(11):2227–2246. • Medical and medication history (including ADRs); current medications, related dosage forms, and routes; patient's tolerance of the forms and/or routes • State of anxiety of the patient and/or family members or caregiver • Use of prescription and over-the-counter medications in the home setting 212 • Usual method of medication administration, such as use of a calibrated spoon or needleless syringe • Usual response to medications • Motor and cognitive responses and their ageappropriateness • Resources available to the patient and family In addition, check and recheck the prescriber's orders because there is no room for error when administering medications to pediatric patients—or any patients for that matter. Carefully perform medication dosage calculations, and check several times for accuracy. Calculations for dosages take into account a variety of information and variables that may affect patient response, and use of body weight formulas (milligrams per kilogram) is recommended (see previous discussion in pharmacology section). In addition to an assessment of the patient, an assessment of the drug and related information is needed, focusing specifically on the drug's purpose, dosage ranges, routes of administration, cautions, and contraindications. The saying that pediatric patients are just “small adults” is incorrect, because every organ in pediatric patients is anatomically and physiologically immature and not fully functioning. As pediatric patients grow older, their weight is still lower, so extreme caution is continually needed when giving them medications. Immature organ and system development will influence pharmacokinetics and thus affect the way the pediatric patient responds to a drug. Organ function may be determined through laboratory testing. The prescriber may order the following studies before beginning drug therapy, as well as during and after drug therapy: hepatic and renal function studies, red blood cell and white blood cell counts, and measurement of hemoglobin and hematocrit levels and serum protein levels. Assessment data to be gathered for the older adult patient may include the following: • Age 213 • Allergies to drugs and food • Dietary habits • Sensory, visual, hearing, cognitive, and motorskill deficits • Financial status and any limitations • List of all health-related care providers, including physicians, dentists, optometrists and ophthalmologists, podiatrists, and alternative medicine health care practitioners such as osteopathic physicians, chiropractors, and nurse practitioners • Past and present medical history • Listing of medications, past and present, including prescription drugs, over-the-counter medications, herbals, nutritional supplements, vitamins, and home remedies • Existence of polypharmacy (the use of more than one medication) • Self-medication practices • Laboratory test results, especially those indicative of renal and liver function • History of smoking and use of alcohol with notation of amount, frequency, and years of use • Risk situations related to drug therapy identified by the Beers Criteria (see the Evidence-Based Practice box above) One way to collect data about the various medications or drugs being taken by the older adult is to obtain the information from the patient and/or caregiver using the brown-bag technique. This is an effective means of identifying various drugs the patient is taking, regardless of the patient's age, and may be used in conjunction with 214 a complete review of the patient's medical history or record. The brown-bag technique requires the patient/caregiver to place all medications used in a bag and bring them to the health care provider. All medications need to be brought in their original containers. A list of medications with generic names, dosages, routes of administration, and frequencies is then compiled. This list of medications is then compared with what is prescribed to what the patient states he or she is actually taking. Medication reconciliation procedures are performed in health care facilities when assessing and tracking medications taken by the patient (see Chapter 5). In addition, the patient's insight into his or her medical problems is a very beneficial piece of information in developing a plan of care. It is also important for the nurse to realize that although older adult patients may be able to provide the required information, many may be confused or poorly informed about their medications and/or health condition. In such cases, consult with a more reliable historian, such as a significant other, family member, or caregiver. Older adult patients may also have sensory deficits that require the nurse to speak slowly, loudly, and clearly while facing the patient. With the older adult patient—as with a patient of any age— thoroughly assess support systems and the patient's ability to take medications safely. Whenever possible with the older adult, health care providers/prescribers need to opt for a nonpharmacologic approach to treatment first, if appropriate. Other data to collect include information about acute or chronic illnesses, nutritional problems, cardiac problems, respiratory illnesses, and GI tract disorders. Laboratory tests related to lifespan considerations that are often ordered include hemoglobin and hematocrit levels, red blood cell and white blood cell counts, blood urea nitrogen level, serum and urine creatinine levels, urine specific gravity, serum electrolyte levels, and protein and serum albumin levels. Human Need Statements 1. Alteration in fluids and nutrients, less than body requirements, related to the impact of age and drug therapy and possible adverse effects 215 2. Ineffective perception related to information about drugs and their adverse effects or about when to contact the prescriber 3. Altered safety needs, risk for injury, related to adverse effects of medications or to the method of drug administration 4. Altered safety needs, risk for injury, related to idiosyncratic reactions to drugs due to age-related drug sensitivity Patient-Centered Care: Lifespan Considerations for the Older Adult Patient A Brief Look at the Sixth Leading Cause of Death in the United States: Alzheimer's Disease • Alzheimer's disease is the sixth-leading cause of death in the United States and the fifth-leading cause of death for people age 65 and older. • Every 66 seconds, someone in the United States develops Alzheimer's disease. • In 2016, an estimated 5.4 million Americans of all ages have Alzheimer's disease. • Of the 5.4 million Americans with Alzheimer's, approximately 5.2 million are age 65 or older and some 200,000 individuals are under the age of 65 (termed younger-onset Alzheimer's). • One in nine people age 65 and older has Alzheimer's disease. • One in three seniors dies with Alzheimer's or another dementia. • In 2015, more than 15 million caregivers provided about 18.1 billion hours of unpaid care. • Family caregivers spend more than $5000 a year caring for someone with Alzheimer's disease. For some families this means missing a vacation; however, for others, it possibly means going hungry. • In 2016, Alzheimer's and other forms of dementias will cost the 216 nation about $236 billion. • Alzheimer's kills more than breast and prostate cancer combined. • It is estimated that by mid-century, someone in the United States will develop Alzheimer's disease every 33 seconds. • By 2050, the number of people age 64 and older with Alzheimer's may nearly triple from 5.2 million to approximately 13.8 million, unless there are medical breakthroughs to prevent/cure the disease. • Of individuals aged 70, 61% of those with Alzheimer's are expected to die before the age of 80 as compared to 30% of those without Alzheimer's. • Alzheimer's is the only disease among the top 10 causes of death in American that cannot be prevented, cured, or slowed. • Ten warning signs of Alzheimer's disease include the following: memory loss that disrupts daily life; challenges in planning or solving problems; difficulty completing familiar tasks at home or work or at leisure; confusion with time or place; difficulty and trouble understanding visual images and spatial relationships; new problems with words while speaking and in writing; misplacing things and losing the ability to retrace steps; decreased or poor judgment; withdrawal from work or social activities; and changes in mood and personality. For a comparison to typical age-related changes, see www.alz.org. • Two abnormal structures in the brain of a person with Alzheimer's include plaques and tangles and are the prime suspects in damaging and killing nerve cells. From 2016 Alzheimer's disease facts and figures. Available at www.alz.org. Planning: Outcome Identification 1. Patient (caregiver, parent, or legal guardian) states measures to enhance nutritional status due to age- and drug-related factors with understanding of major food groups, as well as 217 any adverse drug effects on everyday nutrition (e.g., nausea, vomiting, loss of appetite). 2. Patient (caregiver, parent, or legal guardian) states the importance of adhering to the prescribed drug therapy for its intended therapeutic effects (or takes medication as prescribed with assistance), as well as anticipated adverse effects. 3. Patient contacts the prescriber when appropriate, such as when unusual effects occur during drug therapy. 4. Patient (caregiver, parent, or legal guardian) identifies ways to minimize complications, adverse effects, reactions, and injury to self that are associated with the therapeutic medication regimen, including drinking at least 4 to 6 ounces of water with all oral medications, rotating of subcutaneous injection sites, and adherence to directions provided by the medication order/prescription. Implementation It is always important to emphasize and practice the Nine Rights of medication administration (see Chapter 1) and follow the prescriber's order and/or medication instructions. Each time before you administer a medication, it is the standard of care to systematically and conscientiously check your procedure three times against the following basic “Six Rights”: right patient, right medication/drug, right dose, right route/form, right time, and right documentation. The other three “rights” are also considered at this time. This usually applies for acute care and long-term care inpatient and outpatient situations. For the pediatric patient, some specific nursing actions are as follows: (1) If needed, mix medications in a substance or fluid other than essential foods (e.g., milk, orange juice, or cereal) because the child may develop a dislike for the essential food item(s). Instead, find a liquid or food item that may be used to make the medication(s) taste better. Sherbet or flavored ice cream is often used. Only resort to this intervention if the patient cannot swallow the dosage form or if the taste needs to be made more palatable. (2) Do not add drug(s) to fluid in a cup or bottle because the amount of drug consumed 218 would then be impossible to calculate if the entire amount of fluid is not consumed. (3) Always document special techniques of drug administration so that others involved in the patient's care may benefit from the suggestion. For example, if the child takes an unpleasant-tasting pill, liquid, or tablet after eating a frozen Popsicle, then this information would be valuable to another caregiver. (4) Unless contraindicated and if needed, add small amounts of water or fluids to elixirs to enhance the child's tolerance of the medication. Remember that it is essential for the child to take the entire volume, so remain cautious with this practice and only use an amount of fluid mixture that you know the child will tolerate. (5) Avoid using the word candy in place of the word drug or medication. Medications must be called medicines and their dangers made known to children. Taking medications is no game, and children must understand this for their own safety! (6) Keep all medications out of the reach of children of all ages. Be sure that parents and other family members in the same household understand this and request child-protective lids or tops for their medications. Childproof locks or closures may also be used on cabinets holding medications. (7) Inquire about how the child usually takes medication (e.g., preference of liquid versus pill or tablet dosage forms) and whether there are any helpful hints from the family/caregiver that may be helpful. See the Patient-Centered Care: Lifespan Considerations for the Pediatric Patient box for further information on medication administration beginning with infancy through adolescence. For more information about dosage calculations for medication administration in pediatric patients, an online site providing examples and programs to help with pediatric drug dosage calculations is available at www.testandcalc.com and www.mapharm.com/dosage_calc.htm. Encourage older adult patients to take medications as directed and not to discontinue them or double up on doses unless recommended or ordered to do so by their health care provider/prescriber. The patient or caregiver must understand the treatment- and/or medication-related instructions, especially those related to safety measures, such as keeping all medications out of the reach of children. Transdermal patches provide a different challenge in that if they fall off onto the floor or bedding, a child or 219 infant in that environment may have accidental exposure to the effects of the medication. Serious adverse reactions have been reported concerning the accidental adhering of a transdermal patch to a child/infant while crawling or playing on the floor/carpet. Toxic and even fatal reactions may occur depending on the medication and dosage. Provide written and oral instructions concerning the drug name, action, purpose, dosage, time of administration, route, adverse effects, safety of administration, storage, interactions, and any cautions about or contraindications to its use. Remember that simple is always best! Always try to find ways to make the patient's therapeutic regimen easy to understand. Always be alert to polypharmacy. Be sure the patient or caregiver understands the dangers of multiple drug use. Patient education may prove helpful in preventing and/or minimizing problems associated with polypharmacy. If a nurse practitioner with prescription privileges has the opportunity to review the patient's chart, simplified written instructions must be provided with the purpose of the drug(s), how to best take the medication(s), and a list of drug interactions and adverse effects. Information must be provided in bold, large print. Among the specific interventions that have proved to be helpful in promoting medication safety in the older adult is the use of the Beers Criteria (see the Evidence-Based Practice box). These criteria provide a systematic way of identifying prescription medications that are potentially harmful to older adult patients. The prescriber and nurse must constantly remember that clinical judgment and knowledge base are important in making critical decisions about a patient's care and drug therapy. In addition, keeping abreast of evidence-based nursing, such as application of the Beers Criteria, is important for the nurse to remain current in clinical nursing practice. Specific guidelines for medication administration by various routes are presented in detail in the photo atlas in Chapter 9. In summary, drug therapy across the lifespan must be well thought out, with full consideration to the patient's age, gender, cultural background, ethnicity, medical history, and medication profile. When all phases of the nursing process and the specific lifespan considerations discussed in this chapter are included, there is a better chance of decreasing adverse effects, reducing risks to the 220 patient, and increasing drug safety. Case Study Safety: What Went Wrong? Polypharmacy and the Older Adult © Katrina Brown R.M., a 77-year-old retired librarian, sees several physician specialists for a variety of health problems. She uses the pharmacy at a large discount store but also has prescriptions filled at a nearby pharmacy, which she uses when she does not feel like going into the larger store. Her medication list is as follows: Thiazide diuretic, prescribed for peripheral edema Oral potassium, prescribed to prevent hypokalemia Beta blocker, prescribed for hypertension Warfarin, taken every evening because of a recent history of deep vein thrombosis Multivitamin tablet for seniors 1. What medications may cause problems for R.M.? Explain your answer. 2. What measures can be taken to reduce these problems? R.M. visits the pharmacy to pick up some medications for her “aches and pains.” She has chosen a popular over-the-counter 221 nonsteroidal antiinflammatory drug. Two weeks later, she notices that she has increased bruising on her arms and legs, and that her gums bleed slightly when she brushes her teeth. 3. What went wrong? (Hint: check for potential drug interactions.) How could this problem have been prevented? Evaluation When dealing with lifespan issues as related to drug therapy, observation and monitoring for therapeutic effects as well as adverse effects are critical to safe and effective therapy. You must know the patient's profile and history as well as information about the drug. The drug's purpose, specific use in the patient, simply stated actions, dose, frequency of dosing, adverse effects, cautions, and contraindications need to be listed and kept available at all times. This information will allow more comprehensive monitoring of drug therapy, regardless of the age of the patient. Key Points • There are many age-related pharmacokinetic effects that lead to dramatic differences in drug absorption, distribution, metabolism, and excretion in the young and the older adult. At one end of the lifespan is the pediatric patient, and at the other end is the older adult patient, both of whom are very sensitive to the effects of drugs. • Most common dosage calculations use the milligrams per kilogram formula related to age. Organ maturity may also be considered. It is important for the nurse to know that many elements besides the mathematical calculation itself contribute to safe dosage calculations. Safety 222 must remain the first priority and concern with consideration of the Nine Rights of medication administration (see Chapter 1). • The percentage of the population older than 65 years of age continues to grow, and polypharmacy remains a concern with the increasing number of older adult patients. A current list of all medications and drug allergies must be on their person or with their family/caregiver at all times. • Your responsibility is to act as a patient advocate as well as to be informed about growth and developmental principles and the effects of various drugs during the lifespan and in various phases of illness. Critical Thinking Exercises 1. A mother calls the clinic to ask how to give a tablet to her 4-year-old son. He is refusing to swallow it and won't chew it because it “tastes icky.” The mother says she is ready to force her son to take this medication. What is the nurse's priority action? 2. A woman in her third trimester of pregnancy is having a checkup and asks for aspirin for a headache. What is the nurse's best response? Review Questions 1. The nurse is reviewing factors that influence pharmacokinetics in the neonatal patient. Which factors puts the neonatal patient at risk with regard to drug therapy? (Select all that apply.) 223 a. Higher gastric pH b. Increased peristalsis in the GI tract c. Immature renal function d. Reduced first-pass elimination in the liver e. Decreased protein-binding of medications 2. The physiologic differences in the pediatric patient compared with the adult patient affect the amount of drug needed to produce a therapeutic effect. The nurse is aware that one of the main differences is that infants have which of these factors? a. Increased protein in circulation b. Fat composition lower than 0.001% c. More muscular body composition d. Water composition of approximately 75% 3. While teaching a 76-year-old patient about the adverse effects of his medications, the nurse encourages him to keep a journal of the adverse effects he experiences. This intervention is important for the older adult patient because of which alterations in pharmacokinetics? a. Increased renal excretion of protein-bound drugs b. More alkaline gastric pH, resulting in more adverse effects c. Decreased blood flow to the liver, resulting in altered metabolism d. Less adipose tissue to store fat-soluble drugs 4. When the nurse is reviewing a list of medications taken by an 88-year-old patient, the patient says, “I get dizzy when I stand up.” She also states that she has nearly fainted “a time or two” in the afternoons. Her systolic blood pressure drops 15 points when she stands up. 224 Which type of medication may be responsible for these effects? a. Nonsteroidal antiinflammatory drugs (NSAIDs) b. Cardiac glycosides c. Anticoagulants d. Antihypertensives 5. A pregnant patient who is at 32 weeks’ gestation has a cold and calls the office to ask about taking an over-thecounter medication that is rated as pregnancy category A. Which answer by the nurse is correct? a. “This drug causes problems in the human fetus, so you should not take this medication.” b. “This drug may cause problems in the human fetus, but nothing has been proven in clinical trials. It is best not to take this medication.” c. “This drug has not caused problems in animals, but no testing has been done in humans. It is probably safe to take.” d. “Studies indicate that there is no risk to the human fetus, so it is okay to take this medication as directed if you need it.” 6. The nurse is preparing to administer an injection to a preschool-age child. Which approaches are appropriate for this age group? (Select all that apply.) a. Explain to the child in advance about the injection. b. Provide a brief, concrete explanation about the injection. c. Encourage participation in the procedure. d. Make use of magical thinking. e. Provide comfort measures after the injection. 225 7. The nurse is preparing to give an oral dose of acetaminophen (Tylenol) to a child who weighs 12 kg. The dose is 15 mg/kg. How many milligrams will the nurse administer for this dose? 8. An 82-year-old patient is admitted to the hospital after an episode of confusion at home. The nurse is assessing the current medications he is taking at home. Which method is the best way to assess his home medications? a. Ask the patient what medications he takes at home. b. Ask the patient's wife what medications he takes at home. c. Ask the patient's wife to bring his medications to the hospital in their original containers. d. Contact the patient's pharmacy for a list of the patient's current medications. References Administration on Aging. Aging statistics. [Available at] www.aoa.acl.gov/Aging_Statistics/index.aspx. Alzheimer's Association. Alzheimer's disease facts and figures. [Available at] www.alz.org; 2016. American Geriatrics Society 2015 Beers Criteria Update Expert Panel. American Geriatric Society 2015 updated Beers Criteria for potentially inappropriate medication use in older adults. Journal of the American Geriatrics Society. 2015;63(11):2227–2246. American Geriatrics Society. Expanded AGS Beers Criteria offer new guidance, tools for safer medication use among older adults. [Available at] www.americangeriatrics.org/press/id:5910. Bernius M, Thibodeau B, Jones A, et al. Prevention of 226 pediatric drug calculation errors by prehospital care providers. Prehospital Emergency Care. 2008;12(4):486–494 [(Accessed 12 August 2016)]. Buck ML. Improving pediatric medication safety, part II: evaluating strategies to prevent medication errors. Pediatric Pharm. 2008;14(12). Cajigal S, Tassinari M, Best J. FDA updates labels for pregnant and breastfeeding women. [Available at] www.medscape.com/viewarticle/837337. Centers for Disease Control and Prevention. Health, United States. [Available at] cdc.gov/nchs/data/hus/hus12.pdf#091; 2012. Centers for Disease Control and Prevention. Life expectancy. [Available at] www.cdc.gov/nchs/faststs/lifexpec.htm. Chang CM, Liu PY, Yang YH, et al. Use of the Beers Criteria to predict adverse drug reaction among first-visit elderly outpatients. Pharmacotherapy. 2005;25(6):831–838. Cote CJ, Wilson S. Guidelines for monitoring and management of pediatric patients before, during and after sedation for diagnostic and therapeutic procedures: update, 2016. Pediatrics. 2016;138(1):1– 33. DeDea L. The Beers Criteria: antibiotic and metoprolol dosing. JAAPA. 2010;23(10):12 [Available at] www.jaapa.com/the-beers-criteriaantibiotic-and-metoprolol-dosing/article/179953. Guay D. Geriatric pharmacotherapy updates. American Journal of Geriatric Pharmacotherapy. 2010;8(4):599–609. Hockenberry, M. J., & Wilson, D. (2013). Wong's essentials of pediatric nursing (9th ed.). St. Louis: Elsevier Mosby, Inc. 227 Institute for Safe Medication Practices. Reducing patient harm from opiates. ISMP Medication Safety Alert! High Alert Medication Feature. [Available at] www.ismp.org/newsletters/acutecare/articles/20070222.asp 2007. Institute for Safe Medication Practices. Tablet splitting: do it only when you “half” to, and then do it safely. ISMP Medication Safety Alert!. Acute Care. 2006 [Available at] www.ismp.org/newsletters/acutecare/articles/20060518.asp Keers RN, Williams SD, Cooke J, et al. Causes of medication administration errors in hospitals: a systematic review of quantitative and qualitative evidence. Drug Safety. 2013;36(11):1045–1067. Levy HB, Marcus EL, Christen C. Beyond the Beers Criteria: a comparative overview of explicit criteria. Annals of Pharmacotherapy. 2010;44(12):1968–1975. Loya AM, Gonzalez-Stuart A, Rivera JO. Prevalence of polypharmacy, polyherbacy, nutritional supplement use and potential product interactions among older adults living on the United States– Mexico border: a descriptive, questionnaire-based study. Drugs and Aging. 2009;26(5):423–436. Maher RM, Hanlon JT, Hajjar ER. Clinical consequences of polypharmacy in elderly. Expert Opinion on Drug Safety. 2014;13(1):57–65. McGann E. Medication error prevention: a shared responsibility. Medscape Medical News. [June; 14; Available at] www.medscape.com/viewarticle/744546; 2011. Milton JC, Hill-Smith I, Jackson SH. Prescribing for older people. BMJ (Clinical Research Ed.). 2008;336:606. 228 Molony SL. Beers Criteria for potentially inappropriate medication use in the elderly. Journal of Gerontological Nursing. 2003;29(11):6. Petro-Yura H, Walsh MB. Human needs and the nursing process. Catholic University of America Press: Washington DC; 1978. Petro-Yura H, Walsh MB. Human needs 2 and the nursing process. Catholic University of America Press: Washington DC; 1983. Petro-Yura H, Walsh MB. Human needs 3 and the nursing process. Catholic University of America Press: Washington DC; 1983. Qato DM, Wilder J, Schumm LP, et al. Changes in prescription and over-the-counter medication and dietary supplement use among older adults in the United States, 2005 vs. 2011. JAMA Internal Medicine. 2016;176(4):473–482. Stein J. Polypharmacy common in elderly psychiatric inpatients. Medscape Medical News. [Available at] www.medscape.com/viewarticle/717798; 2010. Takata GS, Mason W, Taketomo C, et al. Development, testing, and findings of a pediatricfocused trigger tool to identify medication-related harm in US children's hospitals. Pediatrics. 2008;121(4):927–935. Tham E, Calmes HM, Poppy A, et al. Sustaining and spreading the reduction of adverse drug events in a multicenter collaborative. Pediatrics. 2011;128(2):438–445. US Food and Drug Administration. Drug research and children. [Available at] www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm1435 US Food and Drug Administration. FDA issues final rule on changes to pregnancy and lactation labeling 229 information for prescription drug and biological products. [Available at] www.fda.gov/NewsEvents/Newsroom/PressAnnouncement 230 4 Cultural, Legal, and Ethical Considerations OBJECTIVES When you reach the end of this chapter, you will be able to do the following: 1. Discuss the various cultural factors that may influence an individual's response to medications. 2. Identify various cultural phenomena affecting health care and use of medications. 3. List the drugs that are more commonly associated with variations in response due to cultural and racial/ethnic factors. 4. Briefly discuss the important components of drug legislation at the state and federal levels. 5. Provide examples of how drug legislation impacts drug therapy, professional nursing practice, and the nursing process. 6. Discuss the various categories of controlled substances, and give specific drug examples in each category. 7. Identify the process involved in the development of new drugs, including the investigational new drug application, the phases of 231 investigational drug studies, and the process for obtaining informed consent. 8. Discuss the nurse's role in the development of new and investigational drugs and the informed consent process. 9. Discuss the ethical principles and how they apply to pharmacology and the nursing process. 10. Identify the ethical principles involved in making an ethical decision. 11. Develop a nursing care plan that addresses the cultural, legal, and ethical care of patients with a specific focus on drug therapy and the nursing process. KEY TERMS Bias Any systematic error in a measurement process. Black box warning A type of warning that appears in a drug's prescribing information and is required by the US Food and Drug Administration (FDA) to alert prescribers of serious adverse events that have occurred with the given drug. Blinded investigational drug study A research design in which the subjects are purposely unaware of whether the substance they are administered is the drug under study or a placebo. This method serves to minimize bias on the part of research subjects in reporting their body's responses to investigational drugs. Controlled substances Any drugs listed on one of the “schedules” of the Controlled Substance Act (also called scheduled drugs). Culture The customary beliefs, social forms, and material traits of a racial, religious, or social group. Double-blind investigational drug study A research design in which both the investigator(s) and the subjects are purposely unaware of whether the substance administered to a given subject is the drug under study or a placebo. This method minimizes bias on the part of both the investigator and the 232 subject. Drug polymorphism Variation in response to a drug because of a patient's age, gender, size, and/or body composition. Ethics The rules of conduct recognized in respect to a particular class or group of human actions. Ethnicity Relating to or characteristic of a human group having racial, religious, language, and other traits in common. Ethnopharmacology The study of the effect of ethnicity on drug responses, specifically drug absorption, metabolism, distribution, and excretion as well as the study of genetic variations to drugs (i.e., pharmacogenetics). Expedited drug approval Acceleration of the usual investigational new drug approval process by the FDA, usually for drugs used to treat life-threatening diseases. Health Insurance Portability and Accountability Act (HIPAA) An act that protects health insurance coverage for workers and their families when they change jobs. It also protects patient information. If confidentiality of a patient is breached, severe fines may be imposed. Informed consent Written permission obtained from a patient consenting to a specific procedure. Investigational new drug (IND) A drug not yet approved for marketing by the FDA but available for use in experiments to determine its safety and efficacy. Investigational new drug application An application that must be submitted to the FDA before a drug can be studied in humans. Legend drugs Another name for prescription drugs. Malpractice A special type of negligence or the failure of a professional and/or individual with specialized education and training to act in a reasonable and prudent way. Narcotic A legal term established under the Harrison Narcotic Act of 1914. The term is currently used in clinical settings to refer to 233 any medically administered controlled substance and in legal settings to refer to any illicit or “street” drug; also referred to as opioid. Negligence The failure to act in a reasonable and prudent manner or failure of the nurse to give the care that a reasonably prudent (cautious) nurse would render or use under similar circumstances. Orphan drugs A special category of drugs that have been identified to help treat patients with rare diseases. Over-the-counter drugs Drugs available to consumers without a prescription. Also called nonprescription drugs. Pharmacogenomics The study of genetics in drug response. Placebo An inactive (inert) substance (e.g., saline, distilled water, starch, sugar) that is not a drug but is formulated to resemble a drug for research purposes. Race Descendants of a common ancestor; a tribe, family, or people believed to belong to the same lineage. Cultural Considerations The United States is a very culturally diverse nation as evidenced by its constantly and rapidly changing demographics. Official projections noted by Colby and Ortman (2015) reflect that between 2014 and 2060, the US population is expected to increase from 319 million to 417 million, reaching close to 400 million in 2051. By 2044, more than half of all Americans are projected to belong to a minority group. Between the years 2014 and 2060, the native population is projected to increase by 62 million, and foreign-born people are expected to account for an increasing share of the total population, reaching some 19% in 2060. The African-American population is expected to increase by 14% by 2060. The Hispanic population is projected to be the third fastest growing group, with an increase from 55 million in 2014 to 119 million in 2060. The Asian population is projected to double to approximately 9.3% of the total population. The Native Hawaiian and Other Pacific Islander 234 population is anticipated to increase by some 100% between 2014 and 2060. The US Census Bureau has also identified the increase in the selection of “some other race” in the discussion of racial-ethnic groups. To address this, a combined race and ethnicity question is under consideration for 2020 within the US Census Bureau datacollection process. The options to select would be identified as white, black, Hispanic/Latino/Spanish origin, American Indian/Alaska Native, Asian, Native Hawaiian/Other Pacific Islander, or some other race or origin. An additional line would be offered under each category for identification of more detail about one's origin, tribe, or race. Examples of this include German, African American, Mexican, Navajo, Asian Indian, and Samoan. However, worth mentioning is the fact that there are other racialethnic groups, not well-known, and are not included in the above listing but are increasing significantly in numbers. One such group, that is a cultural but not an ethnic group, includes the peoples of Appalachia. Of the some 300 plus million Americans in 2010, 25.2 million lived in the Appalachian region with a great variance in Appalachia's 420 counties. Their growth rate was nearly 7% higher as compared to the year 2000, which is slightly lower than the nearly 10% growth rate for the US as a whole. The Appalachian regions include counties within Alabama, Georgia, Kentucky, Maryland, Mississippi, New York, North Carolina, Ohio, Pennsylvania, South Carolina, Tennessee, Virginia, and West Virginia (Appalachian Regional Commission, 2018). The concern for these “newer” cultural, racial-ethnic groups is for their particular health care needs and barriers to health care. Appalachia is associated with being one of the unhealthiest areas in America, and so it is important to expose nursing students—and other students in the health care profession—to their cultural practices and health care beliefs. Resources providing current information about health care and cultural, racial-ethnic groups include the following: www.cdc.gov/minorityhealth/ and www.commonwealthfund.org/publications/issue-briefs/2017/aug/racialethnic-disparities-care. The field of ethnopharmacology provides an expanding body of knowledge for understanding the specific impact of cultural factors on patient drug response. It is hampered by the lack of clarity in 235 terms such as race, ethnicity, and culture. For example, although some researchers have used the term Hispanic to encompass geographic groups as diverse as Puerto Ricans, Mexicans, and Peruvians, others have used it to denote a specific racial group. Cultural assessment needs to be part of the assessment phase of the nursing process. Acknowledgment and acceptance of the influences of a patient's cultural beliefs, values, and customs is necessary to promote optimal health and wellness. Some relevant practices are discussed in the Patient-Centered Care: Cultural Implications box. Influence of Ethnicity and Genetics on Drug Response Pharmacogenomics is the study of how certain genetic traits affect drug response (see Chapter 8). The concept of polymorphism is critical to an understanding of how the same drug may result in very different responses in different individuals. For example, why does a Chinese patient require lower dosages of an antianxiety drug than a white patient? Why does an African-American patient respond differently to antihypertensives than a white patient? Drug polymorphism refers to the effect of a patient's age, gender, size, body composition, and other characteristics on the pharmacokinetics of specific drugs. Factors contributing to drug polymorphism may be categorized into environmental factors (e.g., diet and nutritional status), cultural factors, and genetic (inherited) factors. Patient-Centered Care: Cultural Implications A Brief Review of Common Practices Among Selected Cultural Groups Cultural Group Verbal and Common Health Nonverbal Beliefs and Communication; Alternative Healers Touch/Time 236 Family Biologic Variations African Asian Hispanic Practice folk medicine; employ “root doctors” as healers, spiritualists; Use herbs, oils, and roots Believe in traditional medicine; hot and cold foods; herbs/teas/soups; use of acupuncturist, acupressurist, and herbalist; Tai Chi; QiGong View health as a result of good luck and living right; see illness as a result of doing a bad deed Heat, cold, and herbs used as remedies; Use curandero, spiritualist Asking personal questions of someone met for the first time seen as intrusive and not proper, that is: nurse meeting patient; Direct eye contact seen as rude and are present oriented High respect for others, especially individuals in positions of authority; Not usually comfortable with custom of shaking hands with those of opposite sex; Present oriented Expressing negative feelings seen as impolite; Avoiding eye contact seen as respectful and attentive; Touching acceptable between two persons in conversation 237 Have close, extended family ties; Women play important key role in making health care decisions Keloid formation, sickle cell anemia, lactose intolerance, skin color Have close extended family ties; family's needs more important than individual needs Many drug interactions, lactose intolerance, skin color, thalassemia Have close Lactose extended intolerance, family ties; skin color all family members involved in health care decisions; Past cultural experiences in the family with illness and healing practices holds significant Native American Believe in harmony with nature and ill spirits causing disease; Use medicine man value; Strong adherence to cultural practices Speak in low Have close tone of voice; extended Light touch of family ties; a person's hand emphasis on is preferred family versus a firm handshake as a greeting; Present oriented Lactose intolerance, skin color, cleft uvula problems Giger, J. N. (2017). Transcultural nursing: Assessment & intervention (7th ed.). St Louis: Mosby. Medication response depends greatly on the level of the patient's adherence with the therapy regimen. Yet adherence may vary depending on the patient's cultural beliefs, experiences with medications, personal expectations, family expectations and influence, and level of education. Prescribers must be aware that some patients use alternative therapies, such as herbal and homeopathic remedies, that can inhibit or accelerate drug metabolism and therefore alter a drug's response. Environmental and economic factors (e.g., diet) can contribute to drug response. For example, a diet high in fat has been documented to increase the absorption of some drugs. Malnutrition with deficiencies in protein, vitamins, and minerals may modify the functioning of metabolic enzymes, which may alter the body's ability to absorb or eliminate a medication. Historically, most clinical drug trials were conducted using white men, often college students, as research subjects. However, there are data that demonstrate the impact of genetic factors on drug pharmacokinetics and drug pharmacodynamics or drug response. Some individuals of European and African descent are known to be slow acetylators. This means that their bodies attach acetyl groups to drug molecules at a relatively slow rate, which results in elevated drug concentrations. This situation may warrant lower drug dosages. A 238 classic example of a drug whose metabolism is affected by this characteristic is the antituberculosis drug isoniazid. In contrast, some patients of Japanese descent are more rapid acetylators and metabolize drugs more quickly, which predisposes the patient to subtherapeutic drug concentrations and may require higher drug dosages. Levels of the cytochrome P-450 enzymes (see Chapter 2) are also known to vary between ethnic groups. This has effects on the ability to metabolize many drugs. This can affect plasma drug levels, and therefore the intensity of drug response, at different doses. Groups of Asian patients have been shown to be “poor metabolizers” of certain drugs and often require lower dosages to achieve desired therapeutic effects. In contrast, white patients are more likely to be classified as “ultrarapid metabolizers” and may require higher drug dosages. Variations are also reported between ethnic groups in the occurrence of adverse effects. For example, African-American patients taking lithium may need to be monitored more closely for symptoms of drug toxicity, because serum drug levels may be higher than in white patients given the same dosage. Likewise, Japanese and Taiwanese patients may require lower dosages of lithium. For the treatment of hypertension, thiazide diuretics appear to be more effective in African Americans than in whites. Several additional examples of racial and ethnic differences in drug response are outlined in the Patient-Centered Care: Cultural Implications box. Patient-Centered Care: Cultural Implications Examples of Varying Drug Responses in Different Racial or Ethnic Groups Racial or Ethnic Group African Drug Classification Antihypertensive Response African Americans respond… 239 Americans drugs Asians and Hispanics Antipsychotic and antianxiety drugs • Better to diuretics than to beta blockers and angiotensin-converting enzyme inhibitors. • Less effectively to beta blockers. • Best to calcium channel blockers, especially diltiazem. • Less effectively to single-drug therapy. Asians… • Need lower dosages of certain drugs such as haloperidol. Asians and Hispanics… • Respond better to lower dosages of antidepressants. Chinese… • Require lower dosages of antipsychotics. Japanese… • Require lower dosages of antimanic drugs. NOTE: The comparison group for all responses is whites. Individuals throughout the world share common views and beliefs regarding health practices and medication use. However, specific cultural influences, beliefs, and practices do exist. Awareness of cultural differences is critical for the care of patients because of the constantly changing US demographics. As a result of these changes, attending to each patient's cultural background helps to ensure quality nursing care, including medication administration. For example, some African Americans have health beliefs and practices that include an emphasis on proper diet and rest; the use of herbal teas, laxatives, and folk medicine, prayer, and the “laying on of hands.” Reliance on various home remedies can be an important component of their health practices. Some AsianAmerican patients, especially Chinese individuals, believe in the concepts of yin and yang. Yin and yang are opposing forces that lead to illness or health, depending on which force is dominant in the individual and whether the forces are balanced. Balance produces healthy states. Other common health practices of Asian Americans include use of acupuncture, herbal remedies, and heat. All such beliefs and practices need to be considered—especially when the patient values their use more highly than the use of medications. Many of these beliefs are strongly grounded in religion. Some Native Americans believe in preserving harmony with nature or keeping a balance between the body and mind and 240 the environment to maintain health. Ill spirits are seen as the cause of disease. Some individuals of Hispanic descent view health as a result of good luck and living right and illness as a result of bad luck or committing a bad deed. To restore health, these individuals seek a balance between the body and mind through the use of cold remedies or foods for “hot” illnesses (of blood or yellow bile) and hot remedies for “cold” illnesses (of phlegm or black bile). Hispanics may use a variety of religious rituals for healing (e.g., lighting of candles). Muslim patients turn to God during illness. Health care providers should respect modesty and privacy, limit eye contact, and not touch while talking. If possible, utilize providers that are the same sex of the patient. It is important to remember that these beliefs vary from patient to patient; therefore consult with the patient rather than assume that the patient holds certain beliefs because he or she belongs to a certain ethnic group. Barriers to adequate health care for the culturally diverse US patient population include language, poverty, access, pride, and beliefs regarding medical practices. Medications may have a different meaning to different cultures. Therefore before any medication is administered, complete a thorough cultural assessment. This assessment includes questions regarding the following: • Languages spoken, written, and understood; need for an interpreter • Health beliefs and practices • Past uses of medicine • Use of herbal treatments, folk remedies, home remedies, or supplements • Use of over-the-counter drugs • Usual responses to illness • Responsiveness to medical treatment • Religious practices and beliefs (e.g., many Christian Scientists believe in taking no medications at all) 241 • Support from the patient's cultural community that may provide resources or assistance as needed, such as religious connections, leaders, family members, or friends • Dietary habits Cultural Considerations Related to Drug Therapy and Nursing Practice It is important to be knowledgeable about drugs that may elicit varied responses in culturally diverse patients or those from different racial/ethnic groups. Varied responses may include differences in therapeutic dosages and adverse effects, so that some patients may have therapeutic responses at lower dosages than are typically recommended. For example, in Hispanic individuals taking traditional antipsychotics, symptoms may be managed effectively at lower dosages than the usual recommended dosage range (see the Patient-Centered Care: Cultural Implications box on this page.) Another aspect of cultural care as it relates to drug therapy is the recognition that patterns of communication may differ based on a patient's race or ethnicity. Communication also includes the use of language, tone, volume, as well as spatial distancing, touch, eye contact, greetings, and naming format. It is important to assess and apply these aspects of cultural and racial/ethnic variations to patient care and to drug therapy and the nursing process. One specific example of cultural diversity is the use of verb tense; some languages, such as the Chinese language, do not have numerous verb tenses as compared to the English language. Therefore, very precise instructions must be included in patient education about medication(s) and how to best and safely take them. Avoiding the use of contractions such as can't, won't, and don't is important with patients from other countries to prevent confusion. Instead, use of cannot, will not, and do not is recommended to improve understanding. 242 Legal Considerations Prescription drug use is vital to treating and preventing illness. However, due to safety reasons, its use is regulated by several different agencies, including the Food and Drug Administration (FDA), The Drug Enforcement Agency (DEA), and individual state laws. Traditionally, only medical doctors (MD) and doctors of osteopathy (DO) had the privilege of prescribing medications. Dentists and podiatrists are also allowed to prescribe medications so long as it is within the scope of their practice. In some states, other health care professionals may also prescribe, including licensed physician's assistants (PAs) and advanced practice registered nurses (APRNs) and most recently optometrists. As the number and complexity of prescriptions continue to increase and technology continually changes, so do the laws regarding their use. Even more autonomy has been gained by the professional nurse over his or her nursing practice. With this increasing autonomy comes greater liability and legal accountability; therefore the professional nurse must be aware and duly consider this responsibility as he or she practices. Specific laws and regulations are discussed later and in the nursing process section of this chapter. US Drug and Related Legislation Until the beginning of the twentieth century, there were no federal rules and regulations in the US to protect consumers from the dangers of medications. The various legislative interventions that have occurred have often been prompted by large-scale serious adverse drug reactions (Table 4.1). One example is the sulfanilamide tragedy of 1937. Over 100 deaths occurred in the United States when people ingested a diethylene glycol solution of sulfanilamide that had been marketed as a therapeutic drug. Diethylene glycol is a component of automobile antifreeze solution, and the drug was never tested for its toxicity. Another prominent example is the thalidomide tragedy that occurred in Europe between the 1940s and 1960s. Many pregnant women who took this sedative-hypnotic drug gave birth to seriously deformed infants. 243 TABLE 4.1 Summary of Major US Drug and Related Legislation Name of Legislation (Year) Federal Food and Drugs Act (FFDA, 1906) Sherley Amendment (1912) to FFDA Harrison Narcotic Act (1914) Federal Food, Drug, and Cosmetic Act (FFDCA, 1938; amendment to FFDA) Durham-Humphrey Amendment (1951) to FFDCA Kefauver-Harris Amendments (1962) to FFDCA Controlled Substance Act (1970) Orphan Drug Act (1983) Accelerated Drug Review Regulations (1991) Health Insurance Portability and Accountability Act (1996) Medicare Prescription Drug Improvement and Modernization Act (2003) Provisions/Comments Required drug manufacturers to list on the drug product label the presence of dangerous and possibly addicting substances; recognized the US Pharmacopeia and National Formulary as printed references standards for drugs Prohibited fraudulent claims for drug products Established the legal term narcotic and regulated the manufacture and sale of habit-forming drugs Required drug manufacturers to provide data proving drug safety with FDA review; established the investigational new drug application process (prompted by sulfanilamide elixir tragedy) Established legend drugs or prescription drugs; drug labels must carry the legend, “Caution—Federal law prohibits dispensing without a prescription” Required manufacturers to demonstrate both therapeutic efficacy and safety of new drugs (prompted by thalidomide tragedy) Established “schedules” for controlled substances (Tables 4.2 and 4.3); promoted drug addiction education, research, and treatment Enabled the FDA to promote research and marketing of orphan drugs used to treat rare diseases Enabled faster approval by the FDA of drugs to treat lifethreatening illnesses (prompted by HIV/AIDS epidemic) More commonly known by its acronym, HIPAA; officially required all health-related organizations as well as schools to maintain privacy of protected health information More commonly known as Medicare Part D; provides seniors and persons with disabilities with an insurance benefit program for prescription drugs; the cost of medications is shared by the patient and the federal government AIDS, Acquired immunodeficiency syndrome; FDA, Food and Drug Administration; HIV, human immunodeficiency virus. A recent and significant piece of legislation is the Health 244 Insurance Portability and Accountability Act (HIPAA) of 1996. HIPAA requires all health care providers, health and life insurance companies, public health authorities, employers, and schools to maintain patient privacy regarding protected health information. Protected health information includes any individually identifying information such as patients’ health conditions, account numbers, prescription numbers, medications, and payment information. Table 4.1 provides a timeline summary of major US drug legislation. New Drug Development Research into and development of new drugs is an ongoing process. The pharmaceutical manufacturing industry is a multibillion-dollar industry. Pharmaceutical companies must continuously develop new and better drugs to maintain a competitive edge. The research required for the development of these new drugs may take several years. Hundreds of substances are isolated that never make it to market. Once a potentially beneficial drug has been identified, the pharmaceutical company must follow a regulated, systematic process before the drug can be sold on the open market. This highly sophisticated process is regulated and carefully monitored by the FDA. The primary purpose of the FDA is to protect the patient and ensure drug effectiveness. This US system of drug research and development is one of the most stringent in the world. It was developed out of concern for patient safety and drug efficacy. Much time, funding, and documentation are required to ensure that these two very important objectives are met. Many drugs are marketed and used in foreign countries long before they receive approval for use in the United States. Drug-related calamities are more likely to be avoided by this more stringent drug approval system. The thalidomide tragedy, mentioned earlier, which resulted from the use of a drug that was marketed in Europe but not in the United States, is an illustrative example. A balance must be achieved between making new lifesaving therapies available and protecting consumers from potential drug-induced adverse effects. Historically, the FDA has 245 had less regulatory authority over vitamin, herbal, and homeopathic preparations because they are designated as dietary supplements rather than drugs. In 1994, Congress passed the Dietary Supplement Health and Education Act, which requires manufacturers of such products at least to ensure their safety (although not necessarily their efficacy) and prohibits them from making any unsubstantiated claims in the product labeling. For example, a product label may read “For depression” but cannot read “Known to cure depression.” Reliable, objective information about these kinds of products is limited but is growing as more formal research studies are conducted. In 1998, Congress established the National Center for Complementary and Alternative Medicine as a new branch of the National Institutes of Health. The function of this center is to conduct rigorous scientific studies of alternative medical treatments and to publish the data from such studies. Consumer demand for alternative medicine products continues to drive this process. Patients must exercise caution in using such products and communicate regularly with their health care providers regarding their use. US Food and Drug Administration Drug Approval Process The FDA is responsible for approving drugs for clinical safety and efficacy before they are brought to the market. There are stringent steps, each of which may take years, which must be completed before the drug can be approved. The FDA has made certain lifesaving investigational drug therapies available sooner than usual by offering an expedited drug approval process, also known as “fast track” approval. Acquired immunodeficiency syndrome (AIDS) was the first major public health crisis for which the FDA began granting expedited drug approval. This process allowed pharmaceutical manufacturers to shorten the approval process and allowed prescribers to give medications that showed promise during early phase I and phase II clinical trials to qualified patients with AIDS. In such cases, when a trial continues to show favorable results, the overall process of drug approval is hastened. The concept of expedited drug approval became controversial after the FDA-initiated manufacturer recall of the anti-inflammatory drug 246 rofecoxib (Vioxx) in 2004. This recall followed multiple case reports of severe cardiovascular events, including fatalities, associated with the use of this drug. This unfortunate example has reduced the number of drugs approved via the expedited approval process. More information and specific drugs approved under this fast-track process can be found at www.fda.gov. The drug approval process is quite complex and prolonged. It begins with preclinical testing phases, which include in vitro studies (using tissue samples and cell cultures) and animal studies. Clinical (human) studies follow the preclinical phase. There are four clinical phases. The drug is put on the market after phase III is completed if an investigational new drug application submitted by the manufacturer is approved by the FDA. The collective goal of these phases is to provide information on the safety, toxicity, efficacy, potency, bioavailability, and purity of the new drug. Preclinical Investigational Drug Studies Current medical ethics require that all new drugs undergo laboratory testing using both in vitro (cell or tissue) and animal studies before any testing in human subjects can be done. In vitro studies include testing of the response of various types of mammalian (including human) cells and tissues to different concentrations of the investigational drug. In vitro studies help researchers to determine early on if a substance might be too toxic for human patients. Many prospective new drugs are ruled out for human use during this preclinical phase of drug testing. However, a small percentage are referred for further clinical testing in human subjects. Four Clinical Phases of Investigational Drug Studies Before any testing on humans begins, subjects must provide informed consent, and it must be documented. Informed consent involves the careful explanation to the human test patient or research subject of the purpose of the study, the procedures to be used, the possible benefits, and the risks involved. This explanation is followed by written documentation on a consent form. The informed consent document, or consent form, must be written in a language understood by the patient and must be dated and signed 247 by the patient and at least one witness. Informed consent is always voluntary. By law, informed consent must be obtained more than a given number of days or hours before certain procedures are performed and must always be obtained when the patient is fully mentally competent. The informed consent process may be carried out by a nurse or other health care professional, depending on how a given study is designed. Medical ethics dictate that participants in experimental drug studies be informed volunteers and not be coerced to participate in any way. Therefore informed consent must be obtained from all patients (or their legal guardians) before they can be enrolled in an investigational new drug (IND) study. Research subjects must be informed of all potential hazards as well as the possible benefits of the new therapy. It must be stressed to all patients that involvement in IND studies is voluntary and that any individual can either decline to participate or quit the study at any time without affecting the delivery of any previously agreed-upon health care services. Phase I. Phase I studies usually involve small numbers of healthy subjects rather than those who have the disease that the new drug is intended to treat. The purpose of phase I studies is to determine the optimal dosage range and the pharmacokinetics of the drug and to ascertain if further testing is needed. Blood tests, urinalyses, assessments of vital signs, and specific monitoring tests are also performed. Phase II. Phase II studies involve small numbers of volunteers who have the disease that the drug is designed to diagnose or treat. Study participants are closely monitored to determine the drug's effectiveness and identify any adverse effects. Therapeutic dosage ranges are refined during this phase. If no serious adverse effects occur, the study can progress to phase III. Phase III. Phase III studies involve large numbers of patients who are followed by medical research centers and other types of health care 248 entities. The purpose of this larger sample size is to provide information about infrequent or rare adverse effects that may not yet have been observed during previous smaller studies. Information obtained during this clinical phase helps identify any risks associated with the new drug. To enhance objectivity, many studies are designed to incorporate a placebo. A placebo is an inert substance that is not a drug. Placebos are given to a portion of the research subjects to separate out the real benefits of the investigational drug from the apparent benefits arising out of researcher or subject bias regarding expected or desired results of the drug therapy. A study that incorporates placebo is called a placebo-controlled study. If the study subject does not know if the drug he or she is administered is a placebo or the investigational drug, but the investigator does know, the study is referred to as a blinded investigational drug study. In most studies, neither the research staff nor the subjects being tested know which subjects are being given the real drug and which are receiving the placebo. This further enhances the objectivity of the study results and is known as a double-blind investigational drug study because both the researcher and the subject are “blinded” to the actual identity of the substance administered. Both drug and placebo dosage forms given to patients often look identical except for a secret code that appears on the medication itself and/or its container. At the completion of the study, this code is revealed to determine which study patients received the drug and which were given the placebo. The code can also be broken before study completion by the principle investigator in the event of a clinical emergency that requires a determination of what substance individual patients received. The three objectives of phase III studies are to establish the drug's clinical effectiveness, safety, and dosage range. After phase III is completed, the FDA receives a report from the manufacturer, at which time the drug company submits a new drug application (NDA). The approval of the application paves the way for the pharmaceutical company to market the new drug exclusively until the patent for the drug molecule expires. This is normally 17 years after discovery of the molecule and includes the 10- to 12-year period generally required to complete drug research. Therefore the manufacturer typically has 5 to 7 years after drug marketing to 249 recoup research costs, which are usually in the hundreds of millions of dollars for a single drug. Phase IV. Phase IV studies are postmarketing studies that are voluntarily conducted by pharmaceutical companies to obtain further proof of the therapeutic and adverse effects of the new drug. Data from these studies are gathered for at least 2 years after the drug's release. Often these studies compare the safety and efficacy of the new drug with that of another drug in the same therapeutic category. Some medications make it through all phases of clinical trials without causing any problems among study patients. However, when they are used in the larger general population, severe adverse effects may appear for the first time. If a pattern of severe reactions to a newly marketed drug begins to emerge, the FDA may request that the manufacturer of the drug issue a black box warning or a voluntary recall. A black box warning is the strictest warning from the FDA and indicates that serious adverse effects have been reported with the drug. The drug can still be prescribed; however, the prescriber must be aware of the potential risk and the patient must be warned. Black box warnings are included in the prescribing information of the drug, and the text of the warning has a solid black border, thus the name black box. The number of drugs with black box warnings is substantial, and it should be noted that not all black box warnings are presented in this textbook. For a list of all drugs with black box warnings, the student is directed to www.blackboxrx.com. The FDA or the manufacturer may issue a drug recall anytime a problem with a drug is noted. There are three classes of recall that may be issued: • Class I: The most serious type of recall—use of the drug product carries a reasonable probability of serious adverse health effects or death. • Class II: Less severe—use of the drug product may result in temporary or medically reversible 250 health effects, but the probability of lasting major adverse health effects is low. • Class III: Least severe—use of the drug product is not likely to result in any significant health problems. The FDA has a voluntary program called MedWatch in which professionals are encouraged to report any adverse events seen with newly approved drugs. Information can be found at www.fda.gov/medwatch. Drug information of this kind is continually evolving as new events are observed and reported. Recommended actions also change with time, thus it is imperative to utilize the most current information available along with sound clinical judgment. The Controlled Substance Act requires the scheduling of every controlled drug (Tables 4.2 and 4.3). There are five classes of controlled substances, designated from C-I to C-V. Drugs in the C-I class are defined as drugs with no currently accepted medical use and a high potential for abuse. Drugs in Schedule II are defined as drugs with a medical use and a high potential for abuse. Schedule III drugs are defined as drugs with a moderate to low potential for physical and psychological dependence. Schedule IV drugs are defined as drugs with a low potential for abuse and low risk of dependence. Schedule V drugs are defined as drugs with lower potential for abuse than Schedule IV and consist of preparations containing limited quantities of certain narcotics. Schedule V drugs are generally used for antidiarrheal, antitussive, and analgesic purposes. It should be noted that in 2014, the popular pain medicine hydrocodone (Vicodin, Lortab) was rescheduled from CIII to C-II, and tramadol (Ultram) was rescheduled to C-IV; prior to the change it was a Schedule V. TABLE 4.2 Controlled Substances: Schedule Categories Schedule Abuse Potential Medical Use Dependency Potential 251 C-I C-II C-III High High Less than C-II None Accepted Accepted C-IV C-V Less than C-III Accepted Less than C-IV Accepted Severe physical and psychological Severe physical and psychological Moderate to low physical or high psychological Limited physical or psychological Limited physical or psychological TABLE 4.3 Controlled Substances: Categories, Dispensing Restrictions, and Examples Schedule C-I C-II C-III C-IV Dispensing Examples Restrictions Only with Heroin, lysergic acid diethylamide (LSD), approved protocol marijuana, mescaline, peyote, psilocybin, and methaqualone Written Codeine, cocaine, hydrocodone, hydromorphone, prescription meperidine, morphine, methadone, secobarbital, a pentobarbital, oxycodone, amphetamine, only methylphenidate, and others No prescription refills Container must have warning label Written or Codeine with selected other medications (e.g., oral acetaminophen), pentobarbital rectal suppositories, prescription and dihydrocodeine combination products that expires in 6 months No more than five refills in a 6-month period Container must have warning label Written or Phenobarbital, chloral hydrate, meprobamate, oral benzodiazepines (e.g., diazepam, temazepam, prescription lorazepam), tramadol, and others that expires in 6 months No more than five refills in a 6-month period 252 C-V Container must have warning label Written prescription or over the counter (varies with state law) Medications generally for relief of coughs or diarrhea containing limited quantities of certain opioid controlled substances a Legally permitted to be telephoned in for major emergencies only. If telephoned in, written prescription is required within 72 hours. Legal Considerations Related to Drug Therapy and Nursing Practice State and federal legislation dictate the boundaries for professional nursing practice. Standards of care and nurse practice acts identify the definition of the scope and role of the professional nurse (Box 4.1). Nurse practice acts further define/identify: (1) the scope of nursing practice, (2) expanded nursing roles, (3) educational requirements for nurses, (4) standards of care, (5) minimally safe nursing practice, and (6) differences between nursing and medical practice. In addition, state boards of nursing define specific nursing practices such as rules concerning the administration of intravenous therapy. Additionally, guidelines from professional nursing groups (for example, the American Nurses Association [ANA]) and nursing specialty groups, as well as institutional policies and procedures and state/federal hospital licensing laws, all help to identify the legal boundaries of professional nursing practice. There is also case law or common law consisting of prior court rulings that affect professional nursing practice. Box 4.1 Nurse Practice Acts Nurse Practice Acts (NPAs) are state laws that are instrumental in defining the scope of nursing practice and protect public health, safety, and welfare. In each state, the law directs entry into nursing practice, defines the scope of practices, and identifies disciplinary 253 actions. State boards of nursing oversee this statutory law. NPAs are the most significant part of legislation as related to professional nursing practice. Together, it is NPAs and common law that define nursing practice. The National Council of State Boards of Nursing maintain an online database of each state's NPA, and each state has a website where the NPAs are defined and outlined. For example, if the nurse is practicing in Missouri, Virginia, or West Virginia, the websites are as follows: Missouri: http://pr.mo.gov/nursing-rules-statutes.asp Virginia: www.dhp.virginia.gov/nursing/nursing_laws_regs.htm West Virginia: www.wvrnboard.com/images/pdf/6707.pdf The ANA has developed standards for nursing practice, policy statements, and similar resolutions. The standards describe the scope, function, and role of the nurse and establish clinical practice standards. The ANA Code of Ethics for Nurses with Interpretive Statements (The Code) explains the goals, values, and ethical precepts that direct the nursing profession and will be discussed later in more detail. Nursing specialty organizations also define standards of care for nurses who are certified in specialty areas, such as oncology, surgical care, or critical care. Standards of care help to determine whether a nurse is acting appropriately when performing professional duties. It is critical to safe nursing practice to remain up to date on the ever-changing obligations and standards of practice/care. If standards are not met, the nurse becomes liable for negligence and malpractice (Box 4.2). Current nursing literature remains an authoritative resource for information on new standards of care. State governments and/or state boards of nursing have websites that include links to specific nurse practice acts and standards of care. Box 4.2 Areas of Potential Liability for Nurses Area Failure to Examples Related to Drug Therapy and the Nursing Process Failure to… 254 assess/evaluate • See significant changes in patient's condition after taking a medication • Report the changes in condition after medication • Take a complete medication history and nursing assessment/history • Monitor patient after medication administration Failure to • Lack of adequate monitoring ensure safety • Failure to identify patient allergies and other risk factors related to medication therapy • Inappropriate drug administration technique • Failure to implement appropriate nursing actions based on a lack of proper assessment of patient's condition Medication Failure to… errors • Clarify unclear medication order • Identify and react to adverse drug reactions • Be familiar with medication prior to its administration • Maintain level of professional nursing skills for current practice • Identify patient's identity prior to drug administration • Document drug administration in medication profile Fraud • Falsification of documentation on the medication profile or patient's record • Failure to provide the nursing care that was documented Health care facilities must also adhere to and/or fulfill specific standards of care and strenuous guidelines to maintain accreditation and from governing bodies such as The Joint Commission (TJC), Healthcare Facilities Accreditation Program (HFAP), and Det Norske Veritas (DNV). For years TJC, as the number one choice, has been providing accreditation to hospitals in the US. TJC requires that accredited hospitals fulfill certain standards that essentially define how high-quality, safe patient care should be delivered. There is a focus on leadership standards and quality management; clinical standards seem to be less of a focus as compared to DNV. DNV emerged in 2008 and has been gaining significant ground in the process of hospital accreditation and offers a fresh viewpoint on accreditation by building their process on a set of hospital standards and requirements. The DNV approaches the process differently and is seen as more “facility friendly” but within a stringent accreditation philosophy and with a more qualitymanagement approach. Characteristics of a more clinical focus and collegial approach have made this a very attractive option for health care facilities. HFAP, another nationally recognized health 255 care facility accreditation organization, meets or exceeds the standards required by Centers for Medicare and Medicaid Services (CMS). It provides accreditation to all hospitals, ambulatory care/surgical facilities, mental health facilities, physical rehabilitation facilities, clinical laboratories, and critical access with authority from the CMS. This is a very basic description of the three accrediting bodies and for more information visit: www.jointcommission.org, www.dnvaccreditation.com, and www.hfap.org. Understanding the function of these accrediting bodies is important because of their priority of monitoring standard of patient care. Nurses need to not only understand their own credentialing/licensing/nurse practice acts but also understand the credentialing process and activities associated to their place of employment. Core to this understanding is the knowledge and application of the facility's written policies and procedures and accrediting/credentialing processes. Ethical Considerations as Related to Drug Therapy and Nursing Practice Decisions in health care are seldom made independently of other people and are made with consideration of the patient, family, nurses, and other members of the health care team. All members of the health care team must make a concentrated effort to recognize and understand their own values and be considerate, nonjudgmental, and respectful of the values of others and ethics. The use of drug therapy has evolved from just administering whatever was prescribed to providing responsible drug therapy for the purpose of achieving defined outcomes that improve a patient's quality of life. Ethical principles are useful strategies for members of the health care team (e.g., physician, pharmacist, nurse) and include standards or truths on which ethical actions are made. Some of the most useful principles in nursing and health care, specifically drug therapy, include autonomy, beneficence, nonmaleficence, and veracity (see the Teamwork and Collaboration: Legal and Ethical Principles box). However, day-to-day practice in nursing and health 256 care pose many potential ethical conflicts. Each situation is different and requires compassionate and humane solutions. When answers to ethical dilemmas remain unclear and ethical conflict occurs, then the appropriate action must be based on ethical principles. Teamwork and Collaboration: Legal and Ethical Principles Elements of Liability for Nursing Malpractice Element Duty Example Being responsible for accurate assessment of a patient's intravenous (IV) and site of IV during caustic drug infusion and the timely reporting of changes in the patient's condition Breach of Nurse does not notice that the IV site is swollen, red, painful, and warm duty to touch or that the IV has quit infusing properly Causation Nurse fails to note the signs and symptoms of extravasation at IV site (with a chemotherapy drug or other caustic drug) that results in the need for skin grafting Damage Extensive skin and nerve damage with several surgical skin grafts resulting in limited use of arm Ethical nursing practice is based on fundamental principles of beneficence, autonomy, justice, veracity, and confidentiality (see the Teamwork and Collaboration: Legal and Ethical Principles box below). The Code and the International Council of Nurses (ICN) serve as frameworks of practice and ethical guidelines for all nurses. As previously mentioned, the ANA has developed The Code of Ethics for Nurses (The Code) with Interpretive Statements. The latest revision (2016) was made in response to the complexity of contemporary nursing practice while attempting to more clearly articulate the content, anticipate major advances in health care and to incorporate “aids that would make it richer,” easier to use and more accessible. There are nine provisions within The Code and with interpretive statements to serve as the profession's nonnegotiable ethical standard, provide very clear statements of “ethical values, obligations and duties” of everyone entering the nursing profession and provide an understanding of the nursing profession's 257 commitment to society. The ANA believes that The Code is the promise of this profession to provide the best care to their patients, families, and communities. It is a reflection of the proud “ethical heritage” of nursing and serves as a guide into the future of professional nursing practice. Revisions of The Code may be accessed at www.nursingworld.org/MainMenuCategories/EthicsStandards/CodeofEthicsforNurses and at www.nursingworld.org. The ICN is a federation of over 130 national nurses associations (NNAs) and represents some 16 million nurses throughout the world. It was founded in 1899 and works to ensure quality of nursing care for all as well as sound health care policies globally. The ICN works with agencies of the United Nations, specifically the World Health Organization. To read more about ICN and its worldwide reaching functions, visit www.icn.ch. Teamwork and Collaboration: Legal and Ethical Principles Ethical Terms Related to Nursing Practice Autonomy: Self-determination and the ability to act on one's own; related nursing actions include promoting a patient's decision making, supporting informed consent, and assisting in decisions or making a decision when a patient is posing harm to himself or herself. Beneficence: The ethical principle of doing or actively promoting good; related nursing actions include determining how the patient is best served. Confidentiality: The duty to respect privileged information about a patient; related nursing actions include not talking about a patient in public or outside the context of the health care setting. Justice: The ethical principle of being fair or equal in one's actions; related nursing actions include ensuring fairness in distributing resources for the care of patients and 258 determining when to treat. Nonmaleficence: The duty to do no harm to a patient; related nursing actions include avoiding doing any deliberate harm while rendering nursing care. Veracity: The duty to tell the truth; related nursing actions include telling the truth with regard to placebos, investigational new drugs, and informed consent. Adherence to these ethical principles and codes of ethics ensures that the nurse is acting on behalf of the patient and with the patient's best interest at heart. As a professional, the nurse has the responsibility to provide safe nursing care to patients regardless of the setting, person, group, community, or family involved. Although it is not within the nurse's realm of ethical and professional responsibility to impose his or her own values or standards on the patient, it is within the nurse's realm to provide information and to assist the patient in making decisions regarding health care. There are other patient care situations that need to be considered within the framework of ethical nursing care. The nurse also has the right to refuse to participate in any treatment or aspect of a patient's care that violates the nurse's personal ethical principles. However, this must be done without deserting the patient, and in some facilities the nurse may be transferred to another patient care assignment only if the transfer is approved by the nurse manager or nurse supervisor. The nurse must always remember, however, that The Code requires the nurse to provide nonjudgmental nursing care from the start of the patient's treatment until the time of the patient's discharge. If transferring to a different assignment is not an option because of institutional policy and because of the increase in the acuteness of patients’ conditions and the high patient-tonurse workload, the nurse must always act in the best interest of the patient while remaining an objective patient advocate. Another area of ethical consideration related to drug therapy and the nursing process is the use of placebos. A placebo is a drug dosage form (e.g., tablet, capsule) without any pharmacologic activity due to a lack of active ingredients. However, there may be reported therapeutic responses, and placebos have been found to be 259 beneficial in certain patients, such as those being treated for anxiety. Placebos are also administered frequently in experimental studies of new drugs to evaluate and measure the pharmacologic effects of a new medicine compared with those of an inert placebo. Except in new drug studies, however, placebo use is often considered to be unethical and deceitful, possibly creating mistrust among the nurse, the prescriber, and the patient. In current clinical practice guidelines for pain management, the American Pain Society and the Agency for Health Care Policy and Research recommend the avoidance of placebos because their use is believed to be deceitful and to violate a patient's rights to the highest-quality care possible. Many health care agencies limit the use of placebos to research only to avoid the possible deceit and mistrust. If an order is received for a placebo for a patient, it is within the legal purview of a professional nurse to inquire about the order and to ask why a placebo is being prescribed; the order must never be taken lightly. If administration of the placebo is part of a research study or clinical trial, the informed consent process must be thorough and the patients must be informed of their right to (1) leave the study at any time without any pressure or coercion to stay, (2) leave the study without consequences to medical care, (3) receive full and complete information about the study, and (4) be aware of all alternative options and receive information on all treatments, including placebo therapy, being administered in the study. It is always the nurse's responsibility to provide the highestquality nursing care and to practice within the professional standards of care. Through the discussion of the The Code, the ICN Code of Ethics for Nurses, nurse practice acts, federal and state codes, ethical principles, and the previously mentioned legal principles and legislation, the nurse becomes fully aware of these sources/resources of legal-ethical dimensions of nursing care. They are all readily accessible and provide nurses with a sound, rational framework for professional nursing practice. Legal-ethical concerns of patient care have resulted in many national and international debates across the various health care disciplines. Legislation passed in 1996 through HIPAA addresses these concerns and under these federal regulations (see p. 45), the privacy of patient information is protected, and standards are 260 included for the handling of electronic data about patients. HIPAA also defines the rights and privileges of patients in order to protect privacy without diminishing access to quality health care. The assurance of privacy—even prior to establishment of the HIPAA guidelines—was based on the principle of respect of an individual's right to determine when, to what extent, and under what circumstances private information can be shared or withheld from others, including family members. In addition, confidentiality must be preserved; that is, the individual identities of patients or research study participants are not to be linked to information they provide and cannot be publicly divulged. HIPAA addresses the issues of confidentiality and privacy by prohibiting prescribers, nurses, and other health care providers from sharing with others any patient health care information, including laboratory results, diagnoses, and prognoses, without the patient's consent. Conflicting obligations arise when a patient wants to keep information away from insurance companies, and matters remain complicated and challenging in the era of improving technology and computerization of medical records. Health care facilities continue to work diligently, however, to adhere to HIPAA guidelines and use special access codes to limit who can access information in computerized documents and charts. In summary, federal and state legislation, standards of care, and nurse practice acts provide the legal framework for safe nursing practice, including drug therapy and medication administration. Further, as discussed in Chapter 1, the “Nine Rights” of medication administration with a specific emphasis on the basic “Six Rights” (right patient, drug, dose, time, route, and documentation) are yet another measure for ensuring safety and adherence to laws necessary for protecting the patient. Chapter 1 also discusses other patient rights that are part of the standards of practice of every licensed registered nurse and every student studying the art and science of nursing. Nursing Process Only information on the cultural considerations related to drug therapy and the nursing process will be presented in the following 261 sections. Legal issues and ethical principles are integrated into professional nursing practice, whereas there are specific racialethnic (cultural) factors that need to be addressed in each phase of the nursing process. Assessment A thorough cultural assessment is needed for the provision of culturally competent nursing care. A variety of assessment tools and resources to incorporate into nursing care are provided in Box 4.3. However, various factors must be assessed and then applied to nursing care, specifically drug therapy and the nursing process. Some of the specific questions about the patient's physical, mental, and spiritual health include the following: Box 4.3 Cultural Assessment Tools and Related Web Links • Several cultural assessment tools have been developed over the last decade. Madeline Leininger's Sunrise Model focuses on seven major areas of cultural assessment, including educational, economic, familial and social, political, technologic, religious and philosophic, and cultural values, beliefs, and practices. • Other comprehensive cultural assessment tools include those developed by Andrews and Bowls, 1999; Friedman, Bowden, and Jones, 2003; Giger and Davidhizar, 1999; and Purnell and Pcaulanka, 1998. Rani Srivastava's (2006), found in The Healthcare Professional's Guide to Clinical Cultural Competence (Healthcare Professional's Guides), contains further discussion on how populations are viewed by health care workers and not through the use of ethno-cultural/religious labels. Maintaining Health 262 • For physical health: Where are special foods and clothing items purchased? What types of health education are of the patient's culture? Where does the patient usually obtain information about health and illness? Folklore? Where are health services obtained? Who are the health care providers (e.g., physicians, nurse practitioners, community services organizations, health departments, healers)? • For mental health: What are examples of culturally specific activities for the mind and for maintaining mental health, as well as beliefs about stress reduction, rest, and relaxation? • For spiritual health: What are resources for meeting spiritual needs? Protecting Health • For physical health: Where are special clothing and everyday essentials? What are examples of the patient's symbolic clothing, if any? • For mental health: Who within the family and community teaches the roles in the patient's specific culture? Are there rules about avoiding certain persons or places? Are there special activities that must be performed? • For spiritual health: Who teaches spiritual practices, and where can special protective symbolic objects such as crystals or amulets be purchased? Are they expensive, and how available are they for the patient when needed? 263 Restoring Health • For physical health: Where are special remedies purchased? Can individuals produce or grow their own remedies, herbs, and so on? How often are traditional and nontraditional services obtained? • For mental health: Who are the traditional and nontraditional resources for mental health? Are there culture-specific activities for coping with stress and illness? • For spiritual health: How often and where are traditional and nontraditional spiritual leaders or healers accessed? Human Need Statements 1. Altered sleep needs related to a lack of adherence to cultural practices for encouraging stress release and sleep induction 2. Deficient knowledge (drug therapy) related to lack of experience and information about prescribed drug therapy 3. Altered safety needs related to adverse and unpredictable reaction to drug therapy due to racial/ethnic or cultural factors Planning and Outcome Identification 1. Patient describes specific measures to enhance sleep patterns such as regular sleep habits, decrease in caffeine, meditation, relaxation therapy, journaling sleep patterns, and noting those measures that enhance or take away sleep. 2. Patient lists the various medication(s) with their therapeutic and adverse effects, dosage routes, and specific methods of adequate self-administration, drug interactions, and any other special considerations. 264 3. Patient describes the impact of his or her racial/ethnic influences (e.g., metabolic enzyme differences) on specific medications and the resulting potential for increase in adverse effects, toxicity, and/or increased or decreased effectiveness (medication therapy). Implementation There are numerous interventions for implementation of culturally competent nursing care, but one very important requirement is that nurses maintain current knowledge about various cultures and related activities and practices of daily living, health beliefs, and emotional and spiritual health practices and beliefs. Specifically, knowledge about medications that may elicit varied responses due to racial/ethnic variations is most important with application of concepts of culturally competent care and ethnopharmacology to each patient care situation. Information of particular significance is the impact of cytochrome P-450 enzymes on certain phases of drug metabolism (see previous discussion on p. 49). Specific examples of differences in certain cytochrome P-450 enzymes can be found on p. 49. Consider additional factors, including the patient's verbal and nonverbal communication patterns; health belief systems; identification of health care provider and/or alternate healers; and interpretation of space, time, and touch. For example, with regard to adherence with the treatment regimen, Hispanics with hypertension have been found in some studies to be less likely than African Americans or whites to continue to take medication as prescribed, a finding that may reflect the patients’ health belief systems. Other lifestyle decisions (e.g., use of tobacco or alcohol) may also affect responses to drugs and must be considered during drug administration. In addition, a patient's cultural background and associated socioeconomic status may create a situation that leads the patient to skip pills, split doses, and not obtain refills. This culture of poverty may be a causative factor in noncompliance and requires astute attention and individualized nursing actions. Evaluation Culturally competent nursing care related to drug therapy may be 265 evaluated through the actual compliance (or lack thereof) to the medication regimen(s). Safe, effective, and therapeutic selfadministration of drugs with minimal to no adverse/toxic effects will be present only when the patient is treated as an individual and has a thorough understanding of the medication regimen. Case Study: Teamwork and Collaboration Clinical Drug Trial © Andrew Gentry A patient on the cardiac telemetry unit has had a serious heart condition for years and has been through every known protocol for treatment. The cardiologist has admitted him to a telemetry unit for observation during a trial of a new investigational drug. The patient exclaims, “I have high hopes for this drug. I've read about it on the Internet and the reports are wonderful. I can't wait to get better!” 1. What is the best way for the research nurse to answer this statement? The physician meets with the patient and the research nurse to explain the medication and how the double-blind experimental drug study will work. The purpose of the medication and potential hazards of the therapy are described, as well as the laboratory tests that will be performed to measure the drug's effectiveness. The physician then asks the research nurse to have the patient sign the consent form. When the nurse goes to get the patient's signature, the patient says, “I’ll sign it, but I really didn't understand what 266 that doctor told me about the placebo.” 2. Should the research nurse continue with getting the consent form signed? Explain your answer. 3. The patient tells the research nurse, “How can I make sure I have the real drug and not the fake drug? I really want to see if it will help my situation.” What is the nurse's best response? 4. After a week, the patient tells the research nurse, “I don't see that this drug is helping me. In fact, I feel worse. But I'm afraid to tell the doctor that I want to stop the medicine. What do I do?” What is the nurse's best response? Key Points • A variety of culturally based assessment tools are available for use in patient care and drug therapy. • Drug therapy and subsequent patient responses may be affected by racial and ethnic variations in levels of specific enzymes and metabolic pathways of drugs. • Various pieces of federal legislation, as well as state law, state practice acts, and institutional policies, have been established to help ensure the safety and efficacy of drug therapy and the nursing process. • HIPAA guidelines have increased awareness concerning patient confidentiality and privacy. It is important to understand this federal legislation as it relates to drug therapy and the nursing process. • The Controlled Substance Act of 1970 provides 267 nurses and other health care providers with information on drugs that cause little to no dependence versus those associated with a high level of abuse and dependency. • Always obtain informed consent as needed, with complete understanding of your role and responsibilities as patient advocate in obtaining such consent. • In the IND research process, adhere to the study protocol while also acting as a patient advocate and honoring the patient's right to safe, quality nursing care. • Adhere to legal guidelines, ethical principles, and The Code so that your actions are based on a solid foundation. • Placebo use remains controversial, and if a placebo is ordered, question the prescriber about the specific cause for its use. Critical Thinking Exercises 1. During a busy shift, the nurse is called to the telephone to speak to a family member of Mrs. H., who was admitted with pneumonia. The caller states, “I'm her grandson, and I want to know if that pneumonia she has is that very contagious bug that's going around hospitals. Is she going to die?” The nurse will answer the family member by following which guidelines? 2. The nurse is assessing a newly admitted 85-year-old woman. During the assessment, the nurse finds that the patient is wearing a copper ring around her left ankle. 268 The ankle is cool, pale, swollen with 3+ edema, and the copper ring is actually cutting into the skin. What is the nurse's priority action at this time? Review Questions 1. A patient has been diagnosed with late-stage cancer. After consulting with his family, he tells the nurse, “I would like to try to live long enough to see my granddaughter graduate in 3 months, but after that I don't want any extra treatments.” This patient is demonstrating which of these? a. Veracity b. Beneficence c. Maleficence d. Autonomy 2. When caring for an older adult Chinese patient, the nurse recognizes which of these cultural issues that may influence the care of this patient? a. Chest x-rays are seen as a break in the soul's integrity. b. Hospital diets are interpreted as being healing and healthful. c. The use of herbal products may be an important practice for this patient. d. Being hospitalized is a source of peace and socialization for this culture. 3. A patient is being counseled for possible participation in a clinical trial for a new medication. After the patient meets with the physician, the nurse is asked to obtain the patient's signature on the consent forms. The nurse knows that this “informed consent” indicates which of 269 these? a. Once therapy has begun, the patient cannot withdraw from the clinical trial. b. The patient has been informed of all potential hazards and benefits of the therapy. c. The patient has received only the information that will help to make the clinical trial a success. d. No matter what happens, the patient will not be able to sue the researchers for damages. 4. A new drug has been approved for use, and the drug manufacturer has made it available for sale. During the first 6 months, the FDA receives reports of severe adverse effects that were not discovered during the testing and considers withdrawing the drug. This illustrates which phase of investigational drug studies? a. Phase I b. Phase II c. Phase III d. Phase IV 5. A patient of Japanese descent says that members of her family often have “strong reactions” after taking certain medications, but her white friends have no problems with the same dosages of the same drugs. The nurse recognizes that, because of this trait, which statement applies? a. She may need lower dosages of the medications prescribed. b. She may need higher dosages of the medications prescribed. c. She should not receive these medications because of potential problems with metabolism. 270 d. These situations vary greatly, and her accounts may not indicate a valid cause for concern. 6. When evaluating polymorphism and medication administration, the nurse considers which factors? (Select all that apply.) a. Nutritional status b. Drug route c. Genetic factors d. Cultural beliefs e. Patient's age 7. The nurse is reviewing the four clinical phases of investigational drug studies. Place the four phases in the correct order of occurrence. a. Studies that are voluntarily conducted by pharmaceutical companies to obtain more information about the therapeutic and adverse effects of a drug. b. Studies that involve small numbers of volunteers who have the disease or ailment that the drug is designed to diagnose or treat. c. Studies that involve small numbers of healthy subjects who do not have the disease or ailment that the drug is intended to treat. d. Studies that involve large numbers of patients who have the disease that the drug is intended to treat; these studies establish the drug's clinical effectiveness, safety, and dosage range. 8. A patient shows the nurse an article in the newspaper about a new black box warning and states, “I take this drug! Is it safe for me to take now?” Which of these statements about black box warnings is true? (Select all that apply.) 271 a. Serious adverse effects from the drug have been reported. b. The FDA is asking for a mandatory recall of this drug. c. Serious adverse effects have been reported with this drug, and the patient will not be able to take it again because the risks outweigh the benefits. d. It can still be prescribed as long as the prescriber and patient are aware of the potential risks. e. Pharmacies will no longer be able to dispense this drug to patients. References Appalachian Regional Commission. The Appalachian region: a data overview from the 2012–2016 American Community Survey. [Available at] 2018 www.arc.gov/research/researchreportdetails.asp? REPORT_ID=143. Colby S, Ortman J. Projections of the size and composition of the U.S. population: 2014 to 2060. [Available at] https://census.gov/content/dam/Census/library/publications/ 1143.pdf; 2015. Healthcare Facilities Accreditation Program. [Chicago, IL. Available at] www.hfap.org; 2017. Mukherjee PK, Venkatesh P, Ponnusankar S. Ethnopharmacology and integrative medicine—let the history tell the future. Journal of Ayurveda and Integrative Medicine. 2010;1(2):100–109. US Department of Health and Human Services, Office of Civil Rights. [Summary of the HIPAA privacy rule; Available at] www.hhs.gov/OCR/privacysummary.pdf; 2003. 272 US Food and Drug Administration. [Controlled Substances Act; Available at] www.fda.gov/regulatoryinformation/legislation/ucm148726. US Food and Drug Administration. The FDA's drug review process: ensuring drugs are safe and effective. [Available at] www.fda.gov/drugs/resourcesforyou/consumers/ucm143534 US Food and Drug Administration. MedWatch: the FDA Safety Information and Adverse Event Reporting Program. [Available at] www.fda.gov/Safety/MedWatch/default.htm. US Food and Drug Administration. Timeline: chronology of drug regulation in the United States. [Available at] www.fda.gov/cder/about/history/time1.htm. US Food and Drug Administration, Office of Regulatory Affairs. Compliance policy guidelines, sec 420.200, compendium revisions and deletions (CPG 7132.02). [Available at] www.fda.gov/ora/compliance_ref/cpg/cpgdrg/cpg420200.html. 273 5 Medication Errors Preventing and Responding OBJECTIVES When you reach the end of this chapter, you will be able to do the following: 1. Briefly discuss the following terms related to drug therapy: adverse drug event, adverse drug reaction, allergic reaction, idiosyncratic reaction, medical error, medication error, and medication reconciliation. 2. Identify the most commonly encountered medication errors. 3. Discuss the various issues contributing to the occurrence of medication errors. 4. Identify potential physical and emotional consequences of a medication error to patients. 5. Discuss the impact of culture and age on the occurrence of medication errors. 6. Analyze the various ethical dilemmas related to professional nursing practice associated with medication errors. 7. Identify agencies concerned with prevention of and response to medication errors. 8. Discuss the possible consequences of medication errors to professional nurses and other members of the health care team. 274 9. Develop a nursing framework for the prevention of, response to, reporting of, and documentation of medication errors. KEY TERMS Adverse drug event Any undesirable occurrence related to administration of or failure to administer a prescribed medication. Adverse drug reactions Unexpected, unintended, or excessive responses to medications given at therapeutic dosages (as opposed to overdose); one type of adverse drug event. Allergic reaction An immunologic reaction resulting from an unusual sensitivity of a patient to a certain medication; a type of adverse drug event and a subtype of adverse drug reactions. Idiosyncratic reaction Any abnormal and unexpected response to a medication, other than an allergic reaction, that is peculiar to an individual patient. Medical errors A broad term used to refer to any errors at any point in patient care that cause or have the potential to cause patient harm. Medication errors Any preventable adverse drug events involving inappropriate medication use by a patient or health care professional; they may or may not cause the patient harm. Medication reconciliation A procedure to maintain an accurate and up-to-date list of medications for all patients between all phases of health care delivery. The health care system is very complex and constantly evolving, leading to an increase in the risk for errors. The 1999 landmark Institute of Medicine (IOM) report “To Err is Human” brought medical errors to the public's attention. According to this report, the number of patient deaths from medical errors in US hospitals ranged from 44,000 to 98,000 annually and of those deaths, 275 preventable medication errors were responsible for 7000 deaths per year. It is estimated that 3% to 6.9% of hospitalized patients experience a medication error. The IOM released a similar report in 2006 and a follow-up report in 2010, both of which found no significant change in rates of preventable errors since the original IOM report. One very important issue brought forth in the IOM report is the notion that most medication errors occur as a breakdown in the medication use system, as opposed to being the fault of the individual. One key to preventing errors is the reporting of errors and potential errors. It has been shown that reporting and sharing of errors can prevent the same error from occurring again. It is imperative that the reporting of errors not be punitive toward the reporter. Many health care institutions have moved from a nonpunitive environment to one of “Just Culture.” Just Culture is an environment where, after a systematic review of an error, discipline is applied appropriately. Just Culture recognizes that competent professionals make mistakes but acknowledges that professionals may develop unhealthy habits (i.e., taking shortcuts). Staff members are held accountable for their actions involving such habits. However, when the error is related to a system or process, staff members are held blameless. System weaknesses include failure to implement a Just Culture environment, excessive workload, minimal time for preventive education, and lack of interdisciplinary communication and collaboration. All hospitals are required to analyze medication errors and implement ways to prevent them. Nurses must take the time to report errors, because without reporting, no changes can be made. When errors are reported, trends can be identified and processes can be changed to prevent the errors from occurring again. Nurses must rely on individual policies and procedures of the institution at which they are working. Widely recognized and common causes of error include misunderstanding of abbreviations, illegibility of prescriber handwriting, miscommunication during verbal or telephone orders, and confusing drug nomenclature. The first priority when an error does occur is to protect the patient from further harm. All errors should serve as red flags that warrant further reflection, detailed 276 analysis, and future preventive actions. Most studies have looked at medical errors occurring in hospitals; however, many serious medication errors occur in the home. Errors occurring in homes can be quite harmful, because potent drugs once used only in hospitals are now being prescribed for outpatients. The majority of fatal errors at home involve the mixing of prescription drugs with alcohol or other drugs. Intangible losses resulting from such adverse outcomes include patient dissatisfaction and loss of trust in the health care system. This, in turn, can lead to adverse health outcomes because patients are afraid to seek health services. While the aforementioned IOM study has been instrumental in the discussion and prevention of medication errors within the system of health care, there are other ideas of thought regarding prevention and/or reduction of medication errors. One important new concept focusing on patient safety and error prevention/reduction emphasizes the way nursing students (and others in the health care professions) are educated. Some nursing leaders and health care experts believe that the education of all health professions needs a systemic change. Of particular note is the 2003 report of the IOM, Health Professions Education: A Bridge to Quality, which built upon the IOM report in 2001, Crossing the Quality Chasm: A New Health System for the 21st Century. This study recommended a complete restructuring of clinical education across all health professions. A follow-up initial report came out of a multidisciplinary summit of health profession leaders (2002), and this high-level panel composed of 150 participants recommended the goal of “an outcome-based” education system. This outcomebased education system was recommended in the hopes of better preparation of clinicians to meet both the needs of patients and the requirements of a changing health system (IOM [US] Committee on the Health Professions Education Summit, 2003). With the 2003 IOM Report, Health Professions Education: A Bridge to Quality, all educators were challenged to alter the process of professional development so that health care professionals, including nurses, would graduate with an adequate understanding and acceptance that their jobs consist of caring for individual patients as well as continuously improving the quality, safety, and reliability of the health care systems within which they work. Nurse leaders 277 supported and integrated these findings into the future of nursing education and developed specific competencies related to patientcentered care, interprofessional teamwork and collaboration, evidence-based practice, safety sciences, quality improvement methods, and informatics. These competencies are considered essential elements of future nursing curricula. “QSEN” (Quality and Safety Education for Nurses) is an initiative funded by the Robert Woods Johnson Foundation to support faculty development in order to support and accomplish this paradigm shift in nursing education. These initiatives will continue to be fully integrated into nursing curricula and are important to the assurance of the quality and safety in professional nursing practice. It is important to mention the IOM studies and QSEN initiatives in this chapter because of the impact they have on safety, including medication errors. It is important for nursing students to understand and recognize the significance of all these reports and be a constant changing force within their educational and work environments while constantly working toward high quality standards of professional nursing practice. Medication Errors An adverse drug event is a general term that encompasses all types of clinical problems related to medication use, including medication errors and adverse drug reactions. Adverse drug reactions are unexpected, unintended, or excessive responses to medications given at therapeutic doses. Two types of adverse drug reactions are allergic reaction (often predictable) and idiosyncratic reaction (usually unpredictable). Medication errors are a common cause of adverse health care outcomes and can range from having no significant effect to directly causing patient disability or death. The various subsets of adverse drug events and their interrelationships are illustrated in Fig. 5.1. 278 FIG. 5.1 Diagram illustrating the various classes and subclasses of adverse drug events. ADRs, Adverse drug reactions; AEs, adverse (drug) effects; ARs, allergic reactions; IRs, idiosyncratic reactions. It is important to consider all of the steps involved in the medication use system when discussing medication errors. Identifying, responding to, and ultimately preventing medication errors require an examination of the entire medication use process. Attention must be focused on all persons and all steps involved in the medication use process. A systems approach takes the basic “Nine Rights” one step further and examines the entire health care system, the health care professionals involved, and any other factor that has an impact on the error. Also significant to mention is the occurrence of “near misses.” Drugs commonly involved in severe medication errors include central nervous system drugs, anticoagulants, and chemotherapeutic drugs. “High-alert” medications have been identified as those that, because of their potentially toxic nature, require special care when prescribing, dispensing, and/or administering. High-alert medications are not necessarily involved in more errors than other drugs; however, the potential for patient harm is higher. Some high-alert medications are listed in Box 5.1. High-alert medications will be denoted with a red exclamation point ( ) throughout this textbook. Medication errors also result from the fact that there are drugs that have similarities in spelling and/or pronunciation (i.e., look-alike or sound-alike names). Several acronyms have been created to refer to these drugs, including SALAD (sound-alike, look-alike drugs) and LASA (look-alike, sound-alike). Mix-ups between such drugs are most dangerous 279 when two drugs from different therapeutic classes have similar names. This can result in patient effects that are grossly different from those intended as part of the drug therapy. The Safety and Quality Improvement: Preventing Medication Errors box lists examples of commonly confused drug names. More information on high-alert medications and SALAD can be found at the website of the Institute for Safe Medication Practices (ISMP) at www.ismp.org. Box 5.1 Examples of High-Alert Medications Drug Classes/Categories • Adrenergic agonists, intravenous (IV) (e.g., epinephrine, phenylephrine, norepinephrine) • Adrenergic antagonists, IV (e.g., propranolol, metoprolol, labetalol) • Anesthetic agents, general, inhaled, and IV (e.g., propofol, ketamine) • Antiarrhythmics IV (e.g., lidocaine, amiodarone) • Antithrombotic agents, including warfarin, low–molecular weight heparins, IV unfractionated heparin, factor Xa inhibitors (e.g., fondaparinux. apixaban, rivaroxaban), direct thrombin inhibitors (e.g., argatroban, bivalirudin, dabigatran etexilate), thrombolytics (e.g., alteplase. reteplase, tenecteplase), and glycoprotein IIb/IIIa inhibitors (e.g., eptifibatide) • Cardioplegic solutions • Chemotherapeutic agents, parenteral and oral • Dextrose, hypertonic, 20% or greater • Dialysis solutions, peritoneal and hemodialysis • Epidural or intrathecal medications • Hypoglycemics, oral • Inotropic medications, IV (e.g., digoxin, milrinone) • Insulin, subcutaneous and IV 280 • Liposomal forms of drugs (e.g., liposomal amphotericin B) and conventional counterparts (e.g., amphotericin B desoxycholate) • Moderate sedation agents, IV (e.g., dexmedetomidine, midazolam) • Moderate sedation agents, oral, for children (e.g., chloral hydrate) • Narcotics/opiates, IV, transdermal, oral (including liquid concentrates, immediate and sustained-release formulations) • Neuromuscular blocking agents (e.g., succinylcholine, rocuronium, vecuronium) • Parenteral nutrition preparations • Radiocontrast agents, IV • Sterile water for injection, inhalation and irrigation (excluding pour bottles) in containers of 100 ml or more • Sodium chloride for injection, hypertonic, greater than 0.9% concentration Specific Drugs • epinephrine, subcutaneous • epoprostenol (Flolan), IV • insulin U-500 (special emphasis)a • magnesium sulfate injection • methotrexate, oral, nononcologic use • opium tincture • oxytocin, IV • nitroprusside sodium for injection • potassium chloride for injection concentrates • potassium phosphates injection • promethazine, IV • vasopressin, IV or intraosseous aAll forms of insulin, subQ and IV, are considered a class of high- 281 alert medications. Insulin U-500 has been singled out for special emphasis to bring attention to the need for distinct strategies to prevent the types of errors that occur with this concentrated form of insulin. From Institute for Safe Medication Practices. ISMP's list of high-alert medications. Available at www.ismp.org/Tools/highalertmedications.pdf. Accessed August 18, 2016. Issues Contributing to Errors Medication errors may occur at any step in the medication process: procuring, prescribing, transcribing, dispensing, administering, and monitoring. One study noted that half of all preventable adverse drug events begin with an error at the medication ordering (prescribing) stage. Administration is the next most common point in the process at which medication errors occur, followed by dispensing errors and transcription errors. It is very important for nurses to have good relationships with pharmacists, because the two professions, working together, can have a major impact in preventing medication errors. Hospital pharmacists are usually available 24/7 and serve as great resources when the nurse has any question regarding drug therapy. “Near misses” must also be considered in the process of identifying and addressing medication errors. A near miss is defined as a situation that is not distinguishable from a preventable adverse event except for the outcome. The patient is still exposed to a hazardous situation but without harm either from early detection (of the error) or through luck. The Agency for Healthcare Research and Quality (AHRQ) defines a near miss as an “event or situation that did not produce patient injury, but only because of chance.” An article by the ISMP states that the AHRQ definition is problematic in that it does not clarify whether the harmless error that resulted in the “event” or “situation” reached the patient and that it fails to support the ongoing evaluation of system controls that may help to capture errors or prevent patient harm once the error has reached a patient. This definition implies that the avoidance of patient harm 282 was by pure chance. Surveys completed by the ISMP suggest that “close call” is a better term (close call being an event or situation or error that took place but was identified and captured prior to reaching the patient. Safety and Quality Improvement: Preventing Medication Errors Institute for Safe Medication Practices: Examples of Look-Alike, Sound-Alike Commonly Confused Drug Names Names of Medications carboplatin vs. cisplatin Celebrex vs. Celexa Depakote vs. Depakote ER dopamine vs. dobutamine glipizide vs. glyburide Humulin vs. Humalog Lamictal vs. Lamisil metronidazole vs. metformin MiraLax vs. Mirapex morphine vs. hydromorphone oxycodone vs. OxyContin Paxil vs. Plavix trazodone vs. tramadol Comments Two different antineoplastic drugs Antiinflammatory drug vs. antidepressant drug Same drug; immediate-release vs. extended-release dosage forms Vasopressor drugs of markedly different strengths; dobutamine is also a strong inotropic affecting the heart Two different antidiabetic drugs Short-acting vs. rapid-acting insulin Anticonvulsant/mood stabilizer vs. antifungal drug Antibiotic vs. antidiabetic drug Laxative vs. antiparkinson drug Two opioids with different potencies Oxycodone is available in immediate-release and controlledreleases formulations (i.e., OxyContin) Antidepressant vs. antiplatelet drug Antidepressant vs. analgesic Additional examples can be found at 283 www.ismp.org/Tools/confuseddrugnames.pdf. Accessed August 18, 2016. The Joint Commission, the major accreditation body for many hospitals, began a patient public awareness campaign in 2006 called Speak Up. It encourages patients to take a more active role in their health care by “speaking up” and asking questions. The value of this program is twofold: patients learn more about their illnesses and the care provided, and they can advocate for their own safety at each health care encounter. The ISMP is an excellent resource for medication safety errors and tips for prevention of such errors. The ISMP website is www.ismp.org, and students are encouraged to utilize this throughout their careers. The World Health Organization also has error-reduction tips (Box 5.2). Box 5.2 World Health Organization Collaborating Centre for Patient Safety Solutions and Speak Up Initiatives About Medications and Health The World Health Organization (WHO) posts information on its website regarding initiatives to promote patient safety in medication administration. As the WHO notes, no adverse event should ever occur anywhere in the world if the knowledge exists to prevent it from happening. Knowledge is of little use, however, if it is not applied in practice. The WHO Collaborating Centre for Patient Safety Solutions has developed patient safety initiatives that can serve as a guide in redesigning the patient care process to prevent the inevitable errors from ever reaching patients. Information about the patient safety solutions approved by the WHO center is available at www.ccforpatientsafety.org. These patient safety concerns include avoiding confusion of medications with look-alike, sound-alike names; ensuring correct patient identification; enhancing communication during patient “handovers” between care units or care teams; ensuring performance of the correct procedure at the correct body site; maintaining control 284 of concentrated electrolyte solutions; ensuring medication accuracy at transition points in care; avoiding catheter and tubing misconnections; and promoting single use of injection devices and improved hand hygiene to prevent health care–associated infections. More information about patient safety and safety initiatives is also provided in a national campaign supported by The Joint Commission and the Centers for Medicare and Medicaid. These initiatives encourage patients to take a role in preventing health care errors by becoming more active, involved, and informed regarding all aspects of their health care. The Speak Up campaign features various brochures, posters, and buttons addressing a variety of patient safety issues and encourages the public to do the following: Speak up if you have any questions. Pay attention to your health care. Educate yourself about medical diagnoses and be informed. Ask a family member or friend you trust to be your advocate. Know the medications you take and the reason for taking them. Use a hospital, ambulatory, or urgent care center or other type of health care institution. Participate in all decisions about your treatment. For more information on the use of Speak Up and to look at the materials available, visit www.jointcommission.org/speakup.aspx. Effective use of technologies such as computerized prescriber order entry and bar coding of medication packages has been shown to reduce medication errors. The US Food and Drug Administration (FDA) requires bar codes for all prescription and over-the-counter medications. The cost of implementing current technology, including automated drug dispensing cabinets with electronic charting and computerized order entry, and bar code scanning may cost in excess of $20 million, which can be prohibitive for smaller hospitals. Nonetheless, these various technologic advances have been shown to reduce medication errors. For example, computerized order entry (also known as computerized physician order entry [CPOE]) eliminates handwriting and standardizes many prescribing functions. Bar coding of medications allows the nurse to use electronic devices for verification of correct medication at the patient's bedside. Computer programs are used in the 285 pharmacy to screen for potential drug interactions. Despite all the benefits technology has to offer, workload issues (i.e., nursing staff shortage), inadequate education, or difficulties in using the complex technology can prevent the technology from eliminating errors as it was designed to do. A new set of medication errors have emerged from computerized order entry including overriding allergy or drug interaction alerts and the potential to choose the wrong drug or wrong patient during order entry. The nurse must never assume that technology eliminates potential medication errors and must always question any issue that does not seem correct. Workarounds are common in health care, and although it may be tempting to devise a work-around to the current technology, all health care professionals should avoid work-arounds and follow the steps put into place by their respective organizations. All health professionals have an obligation to double-check any necessary information before proceeding. For the nurse, this includes stopping and checking medication orders and knowing about the drug before administering it. Even the most capable health care provider cannot know everything or have immediate recall of every drug. Thankfully, there are numerous printed and online sources for drug information for health professionals. Patient safety begins in the educational process with nursing students and faculty members. Adopting the philosophy that “no question is a stupid question” allows students to begin their careers with greater confidence and with a healthy habit of self-monitoring. Commonly reported student nurse errors involve the following situations: unusual dosing times, medication administration record issues (unavailability of the record, failure to document doses given resulting in administration of extra doses, failure to review the record before medicating patients), administration of discontinued or “held” medications, failure to monitor vital signs or laboratory results, administration of oral liquids as injections, and preparation of medications for multiple patients at the same time. The most important thing anyone involved in a medication error can do, besides assessing and monitoring the patient, is to report that the error occurred. Effective communication among all members of the health care team contributes to improved patient care. Disruptive physician 286 behavior and lack of institutional response to it are significant factors affecting nurse job satisfaction and nursing staff retention. The majority of working nurses have witnessed or experienced some degree of disruptive behavior by a physician. This type of behavior may not only undermine patient care but also lead to staff dissatisfaction and turnover. Disruptive behavior, as defined by the American Medical Association (AMA), is personal, verbal, or physical conduct that affects or potentially may affect patient care in a negative fashion. These behaviors are classified into four types by the AMA: (1) intimidation and violence, (2) inappropriate language or comments, (3) sexual harassment, and (4) inappropriate responses to patient needs or staff requests. Nurses and other professionals should report any type of disruptive behavior to their supervisors. Fortunately, communication between prescribers and other members of the health care team has improved over the years with newer generations of prescribers. This is due in large part to more progressive approaches in medical education that emphasize a team approach to treating the patient. Teamwork and Collaboration: Legal and Ethical Principles Use of Abbreviations Medication errors often occur as a result of misinterpretation of abbreviations. Therefore, the National Coordinating Council for Medication Error Reporting and Prevention recommends that the following abbreviations be written out in full and the abbreviations avoided. The US Pharmacopeia and Institute of Safe Medication Practices endorse the avoidance of abbreviations whenever possible. NOTE: It is the philosophy of the authors of this textbook to avoid the use of any abbreviations whenever possible. Abbreviations U or u Intended Meaning Units Misinterpretation Correction Mistaken as the number 0 or 4, causing a 10-fold overdose or greater (e.g., 4 U seen as “40” or Use “unit” 287 µg AD, AS, AU 4 u seen as “44”; mistaken as “cc” so dose given in volume instead of units (e.g., “4 u” seen as “4 cc”) Micrograms Mistaken as mg Right ear, left Mistaken as OD, OS, OU (right ear, each ear eye, left eye, each eye) OD, OS, OU Right eye, left Mistaken as AD, AS, AU (right eye, each eye ear, left ear, each ear) BT cc Bedtime Cubic centimeters Discharge or discontinue D/C Mistaken as “BID” (twice daily) Mistaken as “u” (units) Premature discontinuation of medications if D/C (intended to mean “discharge”) was misinterpreted as “discontinue” when followed by a list of discharge medications Mistaken as “IV” or ‘intrajugular” Mistaken as “IM” or “IV” IJ Injection IN Intranasal HS Half strength Mistaken as “bedtime” hs o.d. or OD At bedtime, hours of sleep International Unit Once daily OJ Orange juice Per os By mouth, orally q.d. or Q.D. Every day IU Mistaken as “half-strength” Mistaken as IV (or intravenous) or 10 (ten) Mistaken as “right eye” (ODoculus dexter), leading to oral liquid mediations administered in the eye Mistaken as OD or OS (right or left eye); drugs meant to be diluted in orange juice may be given in the eye “os” can be mistaken as “left eye” (OS: oculus sinister) Mistaken as q.i.d., especially if the period after the “q” or the tail of the “q” is misunderstood as an “i” 288 Use “mcg” Use “right ear,” “left ear,” “each ear” Use “right eye,” “left eye,” or “each eye” Use “bedtime” Use “mL” Use “discharge” and “discontinue” Use “injection” Use “intranasal” or “NAS” Use “halfstrength” or “bedtime” Use “halfstrength” or “bedtime” Use “units” Use “daily” Use “orange juice” Use “PO,” “by mouth,” or “orally” Use “daily” qhs q.o.d. or Q.O.D. Nightly at bedtime Nightly or at bedtime Every other day q1d Daily q6PM, etc. Every evening at 6 qn Mistake as “qhr” or “every hour” Mistaken as “qh” (every hour) Misinterpreted as “QD” (daily) or “q.i.d” (four times daily) if the “O” is poorly written. Mistaken as “q.i.d.” (four times daily) Mistaken as “every 6 hours” PM SC, SQ, sub q ss SSRI SSI i/d TIW UD Use “nightly” Use “nightly” or “at bedtime” Use “every other day” Use “daily” Use “daily at 6 PM” or “6 PM daily” Use “subcut” or “subcutaneously” Subcutaneous SC mistaken as “SL” (or sublingual); SQ mistaken as “5 every”; the “q” in “sub q” has been mistaken as “every” (e.g., a heparin dose ordered “sub q 2 hours before surgery” misunderstood as “every 2 hours before surgery”) Sliding scale Mistaken as “55” Spell out “sliding (insulin) or scale”; use “onehalf” or “ ” (apothecary) Sliding scale Mistaken as selective-serotonin Spell out “sliding regular reuptake inhibitor scale (insulin)” insulin Sliding scale Mistaken as Strong Solution of Spell out “sliding insulin Iodide (Lugol's) scale (insulin)” One daily Mistaken as “tid” Use “1 daily” 3 times a Mistaken as “3 times a day” or Use “3 times week “twice in a week” weekly” As directed Mistaken as unit dose (e.g., Use “as directed” (“ut dictum”) diltiazem 125 mg IV infusion “UD” misinterpreted as meaning to give the entire infusion as a unit [bolus] dose) From Institute for Safe Medication Practices. ISMP's list of error-prone abbreviations, symbols, and dose designations. Available at www.ismp.org/tools/errorproneabbreviations.pdf. Accessed August 19, 2016. Preventing, Responding to, 289 Reporting, and Documenting Medication Errors: a Nursing Perspective Preventing Medication Errors Medication errors are considered to be any preventable event that could lead to inappropriate medication use or harm. The major categories of medication errors are defined by the 2005 National Coordinating Council for Medication Error Reporting and Prevention as (1) no error, although circumstances or events occurred that could have led to an error; (2) medication error that causes no harm; (3) medication error that causes harm; and (4) medication error that results in death. Medication errors may be prevented through a variety of strategies, including: (1) Multiple systems of checks and balances should be implemented to prevent medication errors. (2) Prescribers must write legible orders that contain correct information, or orders entered electronically, if available (see Evidence-Based Practice on CPOE on p. 67). (3) Authoritative resources, such as pharmacists or current (within the last 3 to 5 years) drug references/literature, must be consulted if there is any area of concern or lack of clarity, beginning with the medication order and continuing throughout the entire medication administration process. Do not use faculty members, nursing staff, or fellow nursing students as your authoritative source regarding medications and the safe practice of using appropriate resources. (4) Nurses need to always check the medication order three times before giving the drug and consult with authoritative resources (see earlier in the chapter) if any questions or concerns exist. (5) The basic Nine Rights of medication administration, as stated previously in this chapter, need to be used consistently. Implementing the Rights of medication administration have been shown to substantially reduce the likelihood of a medication error. See the Patient-Centered Care: Lifespan Considerations for the Pediatric Patient box for a discussion of medication errors in pediatric patients and special considerations for this age group. See the Safety and Quality Improvement: Preventing Medication Errors 290 box for a more concise and detailed listing of ways to help prevent medication errors. Evidence-Based Practice Reduction in Medication Errors in Hospitals Due to Adoptions of Computerized Provider Order Entry Systems Review The occurrence of medication errors in hospitals is common, expensive, and sometimes harmful to patients. While medications are used to treat infectious diseases, manage symptoms of chronic disease, and help relieve pain and suffering, there are risks in taking any medication. Each year in the United States, adverse drug events, or injury resulting from the use of medication, result in over 700,000 visits to hospital emergency departments. This study's objective was to develop a national representative estimate of the reduction of medication errors in hospitals utilizing electronic prescribing through CPOE systems. Methodology A systematic literature review was conducted and a random-effects meta-analytic technique used to establish a summary estimate of the effect of CPOE on medication errors. The pooled estimate was then combined with data collected from the 2006 American Society of Health-System Pharmacists Annual Survey, the 2007 American Hospital Association Annual Survey, and its 2008 Electronic Health Record Adoption Database supplement. These sources of data were used to estimate the percentage and absolute reduction in medication errors attributable to CPOE. Findings The use of a CPOE system in the processing of a prescription drug order decreased the likelihood of a medication error on that order by 48%. With the given effect size and the degree of CPOE adoption and use in hospitals in 2008, the researchers estimated a 291 12.5% reduction in medication errors, which equals approximately 17.4 million medication errors averted in the United States in 1 year. The findings of this study suggest that CPOE can substantially reduce the frequency of medication errors within inpatient acute-care settings. However, it is important to mention that these results translate into reduced harm for patients. Application to Nursing Practice The Institute of Medicine estimates that there is an average of at least one medication error per day in hospitalized patients. They also estimate that at least of all medication-related injuries are preventable and that CPOE may be one method to reduce medication errors and patient harm. Nurses deal directly with medication orders and the interpretation of handwriting and incorrect transcription. With computerized charting, the use of electronic entry of medication orders through CPOE may indeed reduce errors resulting from poor handwriting or incorrect transcription. Despite CPOE systems' effectiveness in preventing medication errors, their adoption and use in the United States remains modest, at best. Nurses can advocate for the use of CPOE and even conduct their own professional nursing research regarding the impact of this electronic order system and prevention of medication errors. Future research from various health care disciplines is needed to link the connection between CPOE and prevention of medication errors. Data from Centers for Disease Control (CDC) and Prevention: Medication Safety Program. Centers for Disease Control and Prevention, National Center for Emerging and Zoonotic Infectious Diseases (NCEZID) Division of Healthcare Quality Promotion (DHQP), 2013. Available at www.cdc.gov. Updated November 14, 2013. Accessed February 25, 2014. Responding to, Reporting, and Documenting Medication Errors Responding to and reporting medication errors are part of the professional responsibilities for which the nurse is accountable. If a medication error and/or a near miss occur, they must be reported, 292 regardless of whether the error was made by a nursing student or a professional nurse. Follow health care institution policies and procedures for reporting and documenting the error closely and cautiously. Once the patient has been assessed and urgent safety issues have been addressed, report the error immediately to the appropriate prescriber and nursing management personnel, for example, the nurse manager or supervisor. If the patient cannot be left alone due to deterioration of the patient's condition or the need for close monitoring after the medication error, a fellow nurse or other qualified health care professional should remain with the patient and provide appropriate care while the prescriber is contacted. Follow-up procedures or tests may be ordered or an antidote prescribed. These orders should be implemented as indicated by the prescriber. Remember that the nurse's highest priority at all times during the medication administration process and during a medication error is the patient's physiologic status and safety. Safety and Quality Improvement: Preventing Medication Errors How to Prevent Medication Errors • As the first step to defend against errors, assess information about the drug and the patient including the medication to be given, drug allergies, vital signs, and laboratory test results. • Use two patient identifiers before giving medications. • Never give medications that have not been drawn up or prepared yourself or are prepared and properly labeled by the pharmacy. • Minimize the use of verbal and telephone orders. If used, be sure to repeat the order to confirm with the prescriber. Speak slowly and clearly, and spell the drug name aloud. • List the reason for use of each drug on the medication administration record and any educational materials. 293 • Avoid abbreviations, medical shorthand, and acronyms because they can lead to confusion, miscommunication, and risk of error (see the Teamwork and Collaboration box). • Never assume anything about any drug order or prescription, including route. If a medication order is questioned for any reason (e.g., dose, drug, indication), never assume that the prescriber is correct. Always be the patient's advocate and investigate the matter until all ambiguities are resolved. • Although computerized physician order entry (CPOE) is the norm, if written orders are used, never try to decipher illegibly written orders; instead, contact the prescriber for clarification. Illegible orders fall below applicable standards for quality medical care and endanger patient safety. If in doubt about any part of an order, always check with the prescriber. Compare the medication order against what is on hand by checking for the Right Drug, Right Dose, Right Time, Right Patient, and Right Route. • CPOE systems are generally paired with some type of clinical decision support system (CDSS), which may help prevent errors during medication ordering and dispensing stages. • Never use trailing zeros (e.g., 1.0 mg) in writing and/or transcribing medication orders. Use of trailing zeros is associated with increased occurrence of overdose. For example, “1.0 mg warfarin sodium” could be misread as “10 mg warfarin,” a tenfold dose increase. Instead, use “1 mg” or even “one mg.” • Failure to use leading zeros can also lead to overdose. For example, .25 mg digoxin could be misread as 25 mg digoxin, a dose that is 100 times the dose ordered. Instead, write “0.25 mg.” • Carefully read all labels for accuracy, expiration dates, dilution requirements, and warnings (e.g., black box warnings). • Remain current with new techniques of administration and new equipment. • Use generic names to avoid medication errors due to many sound-alike trade names. • Listen to and honor any concerns expressed by patients. If the 294 patient voices a concern about being allergic to a medication or states that a pill has already been taken or that the medication is not what he or she usually takes—then STOP, listen, and investigate. • Strive to maintain your own health to remain alert, and never be too busy to stop, learn, and inquire. In addition, engage in ongoing continuing education. • Become a member of professional nursing organizations to network with other nursing students or professional nurses to advocate for improved working conditions and to stand up for the rights of nurses and patients. • Know where to find the latest information on which dosage forms can or should not be crushed or opened (e.g., capsules), and educate patients accordingly. • Safeguard any medications that the patient had on admission or transfer so that additional doses are not given or taken by mistake. In such situations, safeguarding is accomplished by compiling a current medication history and resolving any discrepancies rather than ignoring them. • If using paper medication administration records, always verify if they have been rewritten or reentered for any reason, and follow policies and procedures about this action. • Make sure the weight of the patient is always recorded before carrying out a medication order to help decrease dosage errors. • Provide for mandatory recalculation of every drug dosage for high-risk drugs (e.g., highly toxic drugs) or high-risk patients (e.g., pediatric or older adult patients) because there is a narrow margin between therapeutic serum drug levels and toxic levels (e.g., for chemotherapeutic or digitalis drugs, or in the presence of altered liver or kidney function in a patient). • Minimize interruptions while in the process of medication administration and PAY ATTENTION. • Always suspect an error whenever an adult dosage form is dispensed for a pediatric patient. • Seek translators when appropriate—never guess what patients are trying to say. 295 • Educate patients to take an active role in medication error prevention, both in the hospital setting and at home. • Involve yourself politically in advocating for legislation that improves patient safety. Patient-Centered Care: Lifespan Considerations for the Pediatric Patient Medication Errors Of all the ways a pediatric patient may be harmed during medical treatment, medication errors are the most common. As with older adult patients, when medication errors occur, there is a higher risk of death. The findings of several studies indicate that approximately 1 in 10 children who are hospitalized are impacted by a medication error. The most common medication errors in pediatrics are dosing errors. Research has begun to identify some of the groups of pediatric patients who are at highest risk of medication errors. These include the following patients: (1) those younger than 2 years of age; (2) those in intensive care units (ICUs), specifically the neonatal ICU; (3) those in the emergency department between the hours of 4 AM and 8 AM or on the weekend and who are seriously ill; (4) those receiving intravenous and/or chemotherapeutic drugs; and (5) those whose weight has not been determined or recorded. Mathematical dosage calculations for pediatric patients are also problematic. In determination of the correct dosage once the drug has been ordered, the problems of most concern include the following: (1) inability of the nurse to understand/perform the correct calculation or dilution, (2) infrequent use of calculations, and (3) decimal point misplacement, with potential overdosing or underdosing. The following are some of the actions that can be taken to prevent pediatric medication errors: • With pediatric patients, be sure to always express the volume of liquid medications, using metric units. 296 • Have an accurate scale, and make sure patient's weight is documented in kilograms or grams in the computerized prescriber order entry prior to entering orders. • Report all medication errors, because this information is part of the practice of professional nursing and helps in identifying causes of medication error. • Know the drug thoroughly, including its on- and off-label uses, action, adverse effects, dosage ranges, routes of administration, high-alert drug status cautions (see Box 5.1), and contraindications (e.g., Is it recommended for use in pediatric patients?). • Confirm information about the patient each and every time a dose is given, and check three times before giving the drug by comparing the drug order with the patient's medication profile and verifying for the right patient, right drug, right dose, right time, right route, and right documentation (see Chapter 1). • Double-check and verify information in handwritten orders that may be incomplete, unclear, or illegible. • Avoid verbal telephone orders in general. When they are unavoidable, always repeat them back to the prescriber over the telephone. Insist that the prescriber sign off on any emergency in-person verbal orders before leaving the unit. • Avoid distractions while giving medications. • Avoid storing adult, pediatric, and neonatal medications near one another. • Communicate with everyone (e.g., parent, caregiver) involved in patient care. • Make sure all orders are clear and understood with shift changes. For those nurses administering medications to pediatric patients, competency in specialized training needs to be demonstrated and documented. • Use authoritative resources such as current nursing drug reference handbooks and/or drug manufacturer's insert drug information. 297 When a medication error has occurred, complete all appropriate forms—including an incident report—as per the health care institution's policies and procedures, and provide appropriate documentation. Document the medication error, however, by providing only factual information about the error. Documentation should always be accurate, thorough, and objective. Avoid using judgmental words such as error in the documentation. Instead, chart factual information such as the medication that was administered, the actual dose given, and other details regarding the order (e.g., wrong patient, wrong route, and/or wrong time). Also note any observed changes in the patient's physical and mental status. In addition, document the fact that the prescriber was notified and any follow-up actions or orders that were implemented. Patient monitoring should be ongoing. Most facilities require additional documentation when a medication error occurs consisting of an incident report or unusual occurrence report. Always follow health care institution policies and procedures or protocols in completing an incident report. Documentation should include only factual information about the error as well as all corrective actions taken. Complete any additional sections of the form to help with the investigation of the incident. Because these forms are forwarded to the institution's risk management department, this complete and factual information may help prevent errors in the future. Do not document on the patient's chart that an incident report was filled out, and a copy of the incident report should not be kept. Incident reports are not to be placed in the patient's chart. The reporting of actual and suspected medication errors should offer the option of anonymity. This may help to foster improved error reporting and safe medication practices. Internal, institution-based systems of error tracking may generate data to help customize policy and procedure development. All institutional pharmacy departments are required to have an adverse drug event monitoring program. Nurses as well as health care institutions may also be involved in external reporting of medication errors. There are nationwide confidential reporting programs that collect and disseminate safety information on a larger scale. One such program is the US Pharmacopeia Medication Errors Reporting Program (USPMERP). 298 The US Pharmacopeia (USP) has created a nationwide database of medication errors and their causes, as well as potential errors. Any health care professional can report an error by contacting the USPMERP at 800-23-ERROR. Many important institutional changes have been made based on the data collected by this program. MedWatch is another useful error and adverse event reporting program provided by the FDA. Any member of the public can report problems with medications or medical devices via telephone or mail, or online at the FDA website. The ISMPs and the Joint Commission also provide useful information and reporting services to health care providers aimed at safety enhancement. Case Study Safety: What Went Wrong? Preventing Medication Errors © Oliver Hoffmann. During your busy clinical day as a student nurse, the staff nurse assigned to your patient comes to you and says, “Would you like to give this injection? We have a ‘now’ order for Sandostatin (octreotide) 200 mcg subcutaneously. I've already drawn it up; 200 mcg equals 2 mL. It needs to be given as soon as possible, so I drew it up for you to save time.” She hands you a syringe that has 2 mL of a clear fluid in it. 1. Should you give this medication “now,” as ordered? Why or why not? You decide to check the order in the patient's electronic record. The physician ordered, “Octreotide, 200 mcg now, subcutaneously, then 100 mcg every 8 hours as needed.” 299 Before you have a chance to find your instructor, the nurse returns and says, “Your instructor probably won't let you give the injection unless you can show the medication ampules. Here are the ampules I used to draw up the octreotide. Be quick—your patient needs it now!” You show the two ampules and the syringe to your instructor. Together you read the electronic order and then check the ampules. Each ampule is marked “Sandostatin (octreotide) 500 mcg/mL.” 2. If the nurse drew up 2 mL from these two ampules, how much octreotide is in the syringe? How does this amount compare with the amount on the order? The nurse is astonished when you point out that the ampules read “500 mcg/mL.” She goes into the automated medication dispenser and sees two identical boxes of Sandostatin next to each other in the refrigerated section. One box is labeled “100 mcg/mL,” and the other box is labeled “500 mcg/mL.” She then realizes that she chose ampules of the wrong strength of drug and drew up an incorrect dose. 3. What would have happened if you had given the injection? (Consult a nursing drug handbook if needed.) 4. What needs to be done at this point? What contributed to this potential medication error, and how can it be prevented in the future? Notification of Patients Regarding Errors A landmark article published in the Journal of Clinical Outcomes Management in 2001 recognized the obligation of institutions and health care providers to provide full disclosure to patients when errors have occurred in their care. The article not only emphasized the ethical basis for this practice but also addressed the legal implications and was a starting point for understanding the issue of notification of patients regarding medication errors. The point was made that patients who seek attorney services are often motivated primarily by a perceived imbalance in power between themselves and their health care providers and by fear of financial burden. Health care organizations can choose to proactively apologize and 300 accept responsibility for obvious errors and even offer needed financial support (e.g., for travel expenses, temporary loss of wages). Research indicates that such actions help health care organizations to avoid litigation and potentially much larger financial settlements. Possible Consequences of Medication Errors The possible effects of medication errors on patients range from no significant effect to permanent disability and even death in the most extreme cases. However, medication errors may also affect health care professionals, including nurses and student nurses, in a number of ways. An error that involves significant patient harm or death may take an extreme emotional toll on the nurse involved in the error. Nurses may be named as defendants in malpractice litigation, with possibly serious financial consequences. Many nurses choose to carry personal malpractice insurance for this reason, although nurses working in institutional settings are usually covered by the institution's liability insurance policy. Nurses should obtain clear written documentation of any institutional coverage provided before deciding whether to carry individual malpractice insurance. Administrative responses to medication errors vary from institution to institution and depend on the severity of the error. One possible response is a directive to the nurse involved to obtain continuing education or refresher training. Disciplinary action, including suspension or termination of employment, may also occur depending on the specific incident. However, many hospitals have implemented a non-punitive approach to medication errors. Nurses who have violated regulations of their state's nurse practice act may also be counseled or disciplined by their state nursing board, which may suspend or permanently revoke their nursing license. Student nurses, given their lack of clinical experience, must be especially careful to avoid medication errors, as well as errors in general. When in doubt about the correct course of action, students must consult with clinical instructors or more experienced staff nurses. Nonetheless, if a student nurse realizes that he or she has committed an error, the student is to notify the responsible clinical 301 instructor immediately. The patient may require additional monitoring or medication, and the prescriber may also need to be notified. Although such events are preferably avoided, they can ultimately be useful, though stressful, learning experiences for the student nurse. However, student nurses who commit sufficiently serious errors or display a pattern of errors can expect more severe disciplinary action. This may range from a requirement for extra clinical time or repeating of a clinical course to suspension or expulsion from the nursing school program. Errors Related to the Transition of Care Transition of care is a term to describe the movement of a patient from one care facility to another facility or to home. Most errors that occur during the transition of care stem from poor communication between the health care providers. Medication reconciliation is a process in which medications are “reconciled” at all points of entry and exit to/from a health care entity. Medication reconciliation requires patients to provide a list of all the medications they are currently taking (including herbal products and over-the-counter drugs). The prescriber is then to assess those medications and decide if they are to be continued upon transition. Medication reconciliation was designed to ensure that there are no discrepancies between what the patient was taking at home and in the hospital. Medication reconciliation is to occur at entry into the health care institution, upon transfer from surgery, upon transfer into or out of the intensive care unit, and at discharge. Although this seems to be an easy process, numerous problems have been encountered since its inception in 2005 and it has been linked medication errors. The first problem is that many times patients do not know exactly what medications they are taking and may report that they take a “blue pill for blood pressure.” Sometimes the patient may have a list of medications but some of the medications were discontinued prior to admission, and the patient oftentimes fails to provide this vital piece of information. This can lead to the prescriber continuing a medicine based on 302 faulty information. This particular problem has grown because many hospitals now use hospitalists (physicians that only take care of the patient in the hospital), and the primary care provider who has the most accurate list of medications is not involved. Medication reconciliation involves three steps: 1. Verification—Collection of the patient's medication information with a focus on medications currently used (including prescription drugs as well as over-the-counter medications and supplements) 2. Clarification—Professional review of this information to ensure that medications and dosages are appropriate for the patient 3. Reconciliation—Further investigation of any discrepancies and changes in medication orders To ensure ongoing accuracy of medication use, the steps listed need to be repeated at each stage of health care delivery: Admission, status change (e.g., from critical to stable), patient transfer (within or between facilities or provider teams), and discharge (the latest medication list should be provided to the patient to take to his or her next health care provider visit). Some applicable assessment and education tips regarding medication reconciliation are as follows: 1. Ask the patient open-ended questions, and gradually move to yes-no questions to help determine specific medication information. (Details are important, maybe even critical!) 2. Avoid the use of medical jargon or terms. 3. Prompt the patient to try to remember all applicable medications (e.g., patches, creams, eye drops, inhalers, professional samples, injections, dietary supplements). If the patient provides a medication list, make a copy for the patient's chart. 4. Clarify unclear information to the fullest extent possible (e.g., by talking with the home caregiver or the outpatient pharmacy the patient uses). 5. Record the information in the patient's chart as the first step 303 in the medication reconciliation process. 6. Emphasize to the patient the importance of always maintaining a current and complete medication list and bringing it to each health care encounter (e.g., as a wallet card or other list). Also encourage patients to learn the names and current dosages of their medications. Summary The increasing complexity of nursing practice also increases the risk for medication errors. Widely recognized and common causes of error include misunderstanding of abbreviations, illegibility of prescriber handwriting, miscommunication during verbal or telephone orders, and confusing drug nomenclature. The structure of various organizational, educational, and sociologic systems involved in health care delivery may also contribute directly or indirectly to the occurrence of medication errors. Understanding these influences can help the nurse take proactive steps to improve these systems. Such actions can range from fostering improved communication with other health care team members, including students, to advocating politically for safer conditions for both patients and staff. The first priority when an error does occur is to protect the patient from further harm whenever possible. All errors should serve as red flags that warrant further reflection, detailed analysis, and future preventive actions on the part of nurses, other health care professionals, and possibly even patients themselves. Key Points • To prevent medication errors from misinterpretation of the prescriber's orders, avoid abbreviations. Medication errors include giving a drug to the wrong patient, confusing sound-alike and look-alike drugs, administering the wrong drug or wrong dose, giving the drug by the wrong 304 route, and giving the drug at the wrong time. • Measures to help prevent medication errors include being prepared and knowledgeable and taking time to always triple-check for the right patient, drug, dosage, time, and route. It is also important for nurses always to be aware of the entire medication administration process and to take a systems analysis approach to medication errors and their prevention. • Encourage patients to ask questions about their medications and to question any concern about the drug or any component of the medication administration process. • Encourage patients to always carry drug allergy information on their persons and to keep a current list of medications in their wallets or purses and on their refrigerators. This list should include the drug's name, reason the drug is being used, usual dosage range and dosage prescribed, expected adverse effects and possible toxicity of the drug, and the prescriber's name and contact information. • Report medication errors. It is important to include in this documentation assessment of patient status before, during, and after the medication error, as well as specific orders carried out in response to the error. Critical Thinking Exercises 1. Just after the nurse administers an oral antihypertensive 305 drug, the patient asks, “Wasn't that supposed to be a half-tablet? I just took the whole tablet!” The nurse realizes that the patient was given twice the ordered amount. The order was for 25 mg, a half-tablet, and the entire 50-mg tablet was given. At this time, what would the nurse need to say to the patient? What are the nurse's priority actions? 2. The nurse is reviewing the orders on a newly admitted patient and reads this order: “Humalog insulin, 4 U q.d.” What problems, if any, would the nurse identify in this order? Review Questions 1. The nurse keeps in mind that which measures are used to reduce the risk of medication errors? (Select all that apply.) a. When questioning a drug order, keep in mind that the prescriber is correct. b. Avoid abbreviations and acronyms. c. Use two patient identifiers before giving medications. d. Always double-check the many drugs with soundalike and look-alike names because of the high risk of error. e. If the drug route has not been specified, use the oral route. 2. During the medication administration process, it is important that the nurse remembers which guideline? a. When in doubt about a drug, ask a colleague about it before giving the drug. b. Ask what the patient knows about the drug before 306 giving it. c. When giving a new drug, be sure to read about it after giving it. d. If a patient expresses a concern about a drug, stop, listen, and investigate the concerns. 3. If a student nurse realizes that he or she has made a drug error, the instructor should remind the student of which concept? a. The student bears no legal responsibility when giving medications. b. The major legal responsibility lies with the health care institution at which the student is placed for clinical experience. c. The major legal responsibility for drug errors lies with the faculty members. d. Once the student has committed a medication error, his or her responsibility is to the patient and to being honest and accountable. 4. The nurse is giving medications to a newly admitted patient who is to receive nothing by mouth (NPO status) and finds an order written as follows: “Digoxin, 250 mcg stat.” Which action is appropriate? a. Give the medication immediately (stat) by mouth because the patient has no intravenous (IV) access at this time. b. Clarify the order with the prescriber before giving the drug. c. Ask the charge nurse what route the prescriber meant to use. d. Start an IV line, then give the medication IV so that it will work faster, because the patient's status is NPO at 307 this time. 5. The nurse is reviewing medication orders. Which digoxin dose is written correctly? a. digoxin .25 mg b. digoxin .250 mg c. digoxin 0.250 mg d. digoxin 0.25 mg 6. The nurse is administering medications. Examples of high-alert medications include: (Select all that apply.) a. Chemotherapeutic agents b. Antibiotics c. Opiates d. Antithrombotics e. potassium chloride for injection 7. Convert 250 micrograms to milligrams. Be sure to depict the number correctly according to the guidelines for decimals and zeroes. 8. The nurse is performing medication reconciliation during a patient's admission assessment. Which question by the nurse reflects medication reconciliation? a. “Do you have any medication allergies?” b. “Do you have a list of all the medications, including over-the-counter, you are currently taking?” c. “Do you need to take anything to help you to sleep at night?” d. “What pharmacies do you use when you fill your prescriptions?” References 308 American Medical Association. Physicians with disruptive behavior. [Available at] www.amaassn.org/ama/pub/physician-resources/medicalethics/code-medical-ethics/opinion9045.page; 2000. Anderson P, Townsend T. Preventing high-alert medical errors in hospital patients. American Nurse Today. 2015;10(5):18–23. Institute for Safe Medication Practices. Error-prone conditions that lead to student nurse-related errors. ISMP Medication Safety Alert!. Acute Care. 2007;12(21):1–3 [Available at] www.ismp.org/Newsletters/acutecare/articles/20071018.asp Institute for Safe Medication Practices. ISMP's list of error-prone abbreviations, symbols, and dose designations. [Available at] www.ismp.org/Tools/errorproneabbreviations.pdf; 2010. Institute for Safe Medication Practices. ISMP's list of high-alert medications. [Available at] www.ismp.org/Tools/highalertmedications.pdf; 2010. Institute for Safe Medication Practices. Results of Survey on Pediatric Medication Safety: more is needed to protect hospitalized children from medication errors. Part 1. [June 4, 2015; Available at] www.ismp.org. Institute of Medicine (US) Committee on the Health Professions Education Summit. Health professions education: a bridge to quality. Greiner AC, Knebel E. National Academies Press (US): Washington (DC); 2003 [Available at] www.ncbi.nlm.nih.gov/books/NBK221528/. Intravenous Nurses Society. Medication safety (symposium summary). Journal of Infusion Nursing. 2005;28:42–47. 309 The Joint Commission. Speak Up initiatives. [Available at] www.jointcommission.org/speakup.aspx; 2012. Kannampallil TG, Abraham J, Solotskaya A, et al. Learning from errors: Analysis of medication order voiding in CPOE systems. Journal of the American Medical Informatics Association. 2017;24(4):762–768. Long KA. The Institute of Medicine Report: health professions education: a bridge to quality. Policy, Politics, and Nursing Practice. 2003 [Available at] http://journals.sagepub.com/doi/pdf/10.1177/15271544032583 Miliard M. CPOE cuts medication errors, study shows. Healthcare ITNews. [February 22, 2013; Available at] www.healthcareitnews.com/news/cpoe-cutsmedication-errors-study-shows. The National Academies of Sciences, Engineering and Medicine. Crossing the quality chasm: the IOM Health Care Quality Initiative. [Available at] www.nationalacademies.org/hmd/Global/News%20Announ the-Quality-Chasm-The-IOM-Health-Care-QualityInitiative.aspx. Patient Safety Network. Medication errors. [Available at] https://psnet.arhq.gov/primers/primer/23/medicationerrors. Richardson WC, et al. To err is human: building a safer health system. National Academies Press: Washington, DC; 1999. Tham E, Calmes HM, Poppy A, et al. Sustaining and spreading the reduction of adverse drug events in a multicenter collaborative. Pediatrics. 2011;128(2):438–445. US Food and Drug Administration. Avoiding medication mistakes. [Available at] 310 http://fda.gov/ForConsumers/ConsumerUpdates/ucm048644 311 6 Patient Education and Drug Therapy OBJECTIVES When you reach the end of this chapter, you will be able to do the following: 1. Discuss the importance of patient education in the safe and efficient administration of drugs (e.g., prescription drugs, over-the-counter drugs, herbal preparations, dietary supplements). 2. Summarize the various teaching and learning principles appropriate to patient education and drug therapy across the lifespan as applicable to any health care setting. 3. Discuss the three domains of learning…cognitive, affective, and psychomotor…and their importance in patient education. 4. Identify the impact of age on patient education as it relates to drug therapy and the nursing process. 5. Develop an individualized, comprehensive teaching plan for the adult patient as related to drug therapy and the nursing process. KEY TERMS 312 Affective domain The most intangible domain of the learning process. It involves affective behavior, which is conduct that expresses feelings, needs, beliefs, values, and opinions; the feeling domain. Cognitive domain The domain involved in the learning and storage of basic knowledge. It is the thinking portion of the learning process and incorporates an individual's previous experiences and perceptions; the learning/thinking domain. Health literacy The degree to which individuals have the capacity to obtain and then process and understand basic health information as well as basic health information and services needed to make appropriate health decisions Learning The acquisition of knowledge or skill. Psychomotor domain The domain involved in the learning of a new procedure or skill; often called the doing domain. Teaching A system of directed and deliberate actions intended to induce learning. Overview Given the constant change in today's health care climate and increased consumer awareness, the role of the nurse as an educator continues to increase and remains a significant part of patient care, both in and out of the hospital environment. Patient education is essential in any health care setting and is a critical component of quality and safe health care. Without patient education, the highest quality and safest of care cannot be provided. Patient education is also very crucial in assisting patients, family, significant others, and caregivers to adapt to illness, prevent illness, maintain health and wellness, and provide self-care. Patient education is a process, much like the nursing process; it provides patients with a framework of knowledge that assists in the learning of healthy behaviors and assimilation of these behaviors into a lifestyle. The patient education process begins with assessment of the learner, development of appropriate human need statements, planning, 313 implementation, and evaluation. Patient education may be one of the more satisfying aspects of nursing care because it is essential to improved health outcomes and may be easily measured. In fact, in the current era of increasing acuteness of patient conditions and the need to decrease length of stays in hospitals, patient education and family teaching become even more essential to effectively and efficiently meet outcome criteria. Patient education has also been identified as a valued and satisfying activity for the professional nurse. In addition, patient education is a qualifier found in professional and accreditation standards. Health teaching is not only included in the American Nurses Association document Nursing: Scope and Standards of Practice (2004), but it is also one of the grading criteria used by The Joint Commission (formerly known as the Joint Commission on Accreditation of Healthcare Organization [JCAHO]). Visit http://www.thejointcommission.org for more information on accreditation, certification, standards, measurement, and related topics. An additional accreditation organization, Det Norske Veritas DNV (see Chapter 4), has also introduced a patient education–focused program for the introduction of disease-specific standards and certification programs (visit http://www.dnv.org). Contributing to the effectiveness of patient education is an understanding of and attention to the three domains of learning: the cognitive, affective, and psychomotor domains. It is recommended that one or a combination of these domains be addressed in any patient educational session. The cognitive domain refers to the level at which basic knowledge is learned and stored. It is the thinking portion of the learning process and incorporates an individual's previous experiences and perceptions. Previous experiences with health and wellness influence the learning of new materials, and prior knowledge and experience can serve as the foundation for adding new concepts. Thus the learning process begins with the identification of what experiences the person has had with the subject matter or content. However, it is important to remember that thinking involves more than the delivery of new information because a patient must build relationships between prior and new experiences to formulate new meanings. At a higher level in the thinking process, the new 314 information is used to question something that is uncertain, to recognize when to seek additional information, and to make decisions during real-life situations. For example, you would ask the patient if he or she had ever taken pain medication and, if so, how was the experience? Did the patient understand how often to take the pain medication? What did he or she remember about the risks of the medication? The answers to these questions would then help you, the nurse, determine the patient's understanding of the prescribed pain medication and further refine the teaching plan. The affective domain is the most intangible component of the learning process. Affective behavior is conduct that expresses feelings, needs, beliefs, values, and opinions. It is well known that individuals view events from different perspectives and often choose to internalize feelings rather than express them. You must be willing to approach patients in a nonjudgmental manner, listen to their concerns, recognize the nonverbal messages being given, and assess patient needs with an open mind. If you are successful in gaining the trust and confidence of patients and family members, it may have a powerful effect on their attitudes and thus on the learning process. An example would include questions about the effectiveness of pain medication and patient compliance. The patient explains that she only took one dose of the pain medicine because a family member said it was addicting, and so she was in significant pain. Once the situation is further assessed, and it has been determined that the opinion about the pain medication being addictive was incorrect, you can provide accurate information with proper instructions so that the patient experiences increased comfort and pain is adequately controlled. The psychomotor domain involves the learning of a new procedure or skill and is often called the doing domain. Learning is generally accomplished by demonstration of the procedure or task using a step-by-step approach with return demonstrations by the learner to verify whether the procedure or skill has been mastered. An example would be the use of return demonstration with an individual who is a newly diagnosed diabetic and has a prescription for insulin injections at home. Using a teaching approach that engages these domains—whether one, two, or a combination of all three—will certainly add to the quality and 315 effectiveness of patient education sessions and subsequent learning. The result of effective patient education is learning. Learning is defined as a change in behavior, and teaching as a sharing of knowledge. Although you may never be certain that patients will take medications as prescribed, you may carefully assess, plan, implement, and evaluate the teaching you provide to help maximize outcome criteria. Just like the nursing process, the medication administration process and the teaching-learning process provide systematic frameworks for professional nursing practice. The remainder of this chapter provides a brief look at patient education as related to the nursing process and drug therapy. Assessment of Learning Needs Related to Drug Therapy As previously mentioned, the patient education process is similar to the nursing process. As with the nursing process, a very important facet of the patient education process is a thorough assessment of learning needs. This may be incorporated as part of the health assessment interview. Complete this assessment before patients begin any form of drug therapy. As related to patient education and drug therapy, assessment includes gathering subjective and objective data about the following: • Adaptation to any illnesses • Age • Barriers to learning (Box 6.1) Box 6.1 Strategies to Enhance Patient Education and Reduce Barriers to Learning • Work with available educational resources in nursing and pharmacy to collect or order and distribute materials 316 about drug therapy. Make sure that written materials are available to all individuals and are prepared on a reading level that is most representative of the geographical area, such as an eighth-grade reading level. Most acute care and other health care facilities have electronic resources, so that printing educational materials is easy. Some examples of electronic or computerized programs are Micromedex and Lexi-PALS; these offer patient pamphlets that are in different languages and at appropriate reading levels. • Be sure that written and verbal instructions are available in the language most commonly spoken, such as Spanish. Identify resources within the health care institution and in the community that can provide assistance with translation, such as nurses or other health care providers who are proficient in Spanish and other languages. Have the information available so that education is carried out in a timely and effective manner. • Perform a cultural assessment that includes questions about level of education, learning experiences, past and present successes of therapies and medication regimens, language spoken, core beliefs, value system, meaning of health and illness, perceived cause of illness, family roles, social organization, and health practices or lack thereof. • Make sure that written materials are available on the most commonly used medications and that all materials are updated annually to ensure that information is current. • Have available information for patients on how they can prevent medication errors. The Institute for Safe Medication Practices offers informative pamphlets on the patient's role in preventing medication errors as well as web-based resources such as alerts for consumers with the proper citation. • Work collaboratively in the health care setting, inpatient and outpatient, to develop a listing of medications that may be considered error prone, such as cardiac drugs, chemotherapeutic drugs, low–molecular-weight heparin, digoxin, metered-dose inhaled drugs, and acetaminophen. 317 Lack of time for patient education is often a concern for nurses, but efforts should be undertaken to make materials available and to review these with patients and those involved in their care. Use all available resources, such as videotapes, verbal instructions, pictures, and other health care providers. • For the adolescent, be sure to provide clear and simple directions for each medication, including clarification of information that may well be misinterpreted. For example, teenage girls may have the false idea that oral contraceptives prevent them from contracting sexually transmitted diseases. • Use readability tools in the development of patient education materials if you are involved in this process. Several tools are available, such as the SMOG (Simple Measure of Gobbledygook) readability measure and the Fry readability formula. It is important to know that evidenced-based measures such as these are available to help in the creation of written materials and verbal instructions for patients. Online resources include http://www.readabilityformulas.com/smog-readabilityformula.php and http://www.readabilityformulas.com/fry-graphreadability-formula.php. • Never wait until discharge to teach patients. Include family or caregivers whenever possible, so that they become contributors to patient education and not barriers! • Cognitive abilities • Compliance with previous and/or current therapies; • Coping mechanisms • Cultural background • Developmental status for age group with attention to cognitive and mental processing abilities 318 • Education received including highest grade level completed and literacy level • Educational resources • Emotional status • Environment at home and at work • Financial status/issues/concerns • Folk medicine, home remedies, or use of alternative/complementary therapies (e.g., physical therapy, chiropractic therapy, osteopathic medicine, meditation, yoga, aromatherapy) • Generational differences; for example, Generation Y individuals are technologically dependent and need immediate feedback • Health beliefs, including beliefs about health, wellness, and/or illness • Health literacy (Box 6.2) Box 6.2 A Brief Look at Health Literacy • According to the National Assessment of Adult Literacy (NAAL; available at National Center for Education Statistics, Washington, DC or @ nces.ed.gov; naal@ed.gov), only 12% of adults have proficient health literacy, meaning that 9 out of 10 adults lack the basic skills needed to manage their health and prevent disease. It further states that 14% of adults have below basic health literacy and are more likely to report their health as poor and to lack health insurance than those adults with proficient health literacy. • As related to patient education, assessing and addressing health literacy is only one aspect, but a very important aspect, of health communication and the cognitive domain 319 of learning. • If there is health illiteracy, studies have shown that issues of noncompliance to treatment regimens and disease complications as well as difficulty accessing health care are problematic, contributing to poor health as well as higher health care costs. • Health illiteracy has been associated with less education, lower socioeconomic status, decrease in sensorial abilities, and multiple disease processes, so assessment of these factors is important to individualized patient education. • Other areas to assess related to health literacy include reading level, ability to follow directions/instructions, as well as ability to manage everyday living activities such as self-care, grocery shopping, and meal preparation. • Assessment of health literacy must be done with much sensitivity and not only relates to education but also to levels of stress/inability to cope with a new diagnosis/process and with new and complex information (e.g., patients with a higher level of education who are stressed and unable to process due to a disturbing diagnosis). • Hierarchy of needs • Language(s) spoken • Level of knowledge/understanding about past and present medical conditions, medical therapy, and drug therapy • Limitations (physical, psychological, cognitive, and motor) • Medications currently taken (including over-thecounter drugs, prescription drugs, and herbal products) • Misinformation about drug therapy • Mobility and motor skills 320 • Motivation level and/or interest in health maintenance • Nutritional status and dietary practices • Past and present health behaviors • Past and present experience/success/failure with therapies, especially drug therapy • Patient resources such as social support and transportation • Psychosocial growth and development levels based on different developmental stages (Box 6.3) Box 6.3 General Teaching and Learning Principles • Make learning patient-centered and individualized to each patient's needs, including his or her learning needs. This includes assessment of the patient's cultural beliefs, educational level, previous experience with medications, level of growth and development (to best select a teaching-learning strategy), age, gender, family support system, resources, preferred learning style, and level of sophistication with health care and health care treatment. • Adult learning principles include the following: learning is related to a need/deficit; is person centered; and is reinforced by application and prompt feedback with the nature of learning changing frequently. • New information will draw on past experiences. • Your role as patient educator is that of facilitation. • Assess the patient's motivation and readiness to learn. • Assess the patient's ability to use and interpret label information on medication containers. • Some studies have shown that as much as 20% of the US 321 population is functionally illiterate. Therefore, ensure that educational strategies and materials are at a level that the patient is able to understand, while taking care not to embarrass the patient. • If a patient is illiterate, he or she still needs to be instructed on safe medication administration. Use pictures, demonstrations, and return demonstrations to emphasize instructions. • Consider, assess, and appreciate language and ethnicity during patient teaching. Make every effort to educate non–English-speaking patients in their native language. Ideally the patient needs to be instructed by a health professional familiar with the patient's clinical situation who also speaks the patient's native language. At the very least, provide the patient detailed written instructions in his or her native language. • Assess the family support system for adequate patient teaching. Family living arrangements, financial status, resources, communication patterns, the roles of family members, and the power and authority of different family members must always be considered. • Make the teaching-learning session simple, easy, fun, thorough, effective, and not monotonous. Make it applicable to daily life, and schedule it at a time when the patient is ready to learn. Avoid providing extraneous information that may be confusing or overwhelming to the patient. • Remember that learning occurs best with repetition and periods of demonstration and with the use of audiovisuals and other educational aids. • Patient teaching must focus on the various processes in the cognitive, affective, and/or psychomotor domains (see earlier discussion). • Consult online resources for help in obtaining the most up-to-date and accurate patient teaching materials and information. 322 • Race and/or ethnicity • Readiness to learn • Relationships with family, significant other, and/or caregiver relationships and their level of support • Religion, religious beliefs, spirituality • Risk for noncompliance (visit http://www.talkaboutrx.org) • Self-care ability • Sensory status During the assessment of learning needs, be astutely aware of the patient's verbal and nonverbal communication. Often a patient will not tell you how he or she truly feels. A seeming discrepancy is an indication that the patient's emotional or physical state may need to be further assessed in relation to his or her actual readiness and motivation for learning. Use of open-ended questions is encouraged, because they stimulate more discussion and greater clarification from the patient than closed-ended questions that require only a “yes” or “no” answer. Assess levels of anxiety. It is well documented that mild levels of anxiety have been identified as being motivating, whereas moderate to severe levels may be obstacles to learning. In addition, if there are physical needs that are not being met, such as relief from pain, vomiting, or other physical distress, these needs become obstacles to learning. These physical issues must be managed appropriately before any patient teaching occurs. Human Need Statements Related to Learning Needs and Drug Therapy Some of the human needs statements related to learning needs and drug therapy are as follows: 323 • Autonomous choice • Effective perception • Self-esteem • Self-actualization • Self-control • Self-determination Human need statements that may be appropriate to learning needs develop out of objective and/or subjective data showing that there is limited understanding, no understanding, or misunderstanding of the medication and its action, indications, adverse reactions, toxic effects, drug-drug and/or drug-food interactions, cautions, and contraindications. The statements may also reflect decreased cognitive ability or impaired motor skill needed to perform self-medication. These human need statements may further address noncompliance in that the patient does not comply with or adhere to the instructions given about the medication. Noncompliance is usually a patient's choice. Although noncompliance is usually a patient decision, other factors need to be assessed to determine the cause of the noncompliance (e.g., lack of ability of the parent, family, or caregiver to administer the medication; other physical, emotional, or socioeconomic factors). These factors are associated with the human need statements listed above and will help provide a patient-centered approach to the plan of care. Planning: Outcome Identification as Related to Learning Needs and Drug Therapy The planning phase of the teaching-learning process occurs as soon as a learning need has been assessed and then identified in the patient, family, or caregiver. With mutual understanding, the nurse and patient identify outcome criteria that are associated with the identified human need statements and are able to relate them to the 324 specific medication the patient is taking. Planning will identify the methods to be used that will meet the patient's educational needs. Outcome identification will include if an outcome is a cognitive (knowledge) change, a psychomotor (performance of a skill) change, or an affective (attitude or feeling/emotion) change. The following is an example of outcome identification related to a human need statement of altered safety needs, risk for injury for a patient who is self-administering an oral antidiabetic drug and has many questions about the medication therapy. Sample outcomes identification: “Patient safely self-administers the prescribed oral antidiabetic drug within a given time frame decreasing the patient's risk for injury” and “Patient remains without signs and symptoms of overmedication/injury while taking an oral antidiabetic drug, such as hypoglycemia with tachycardia, palpitations, diaphoresis, hunger, and fatigue.” When drug therapy outcomes are identified, appropriate time frames for meeting outcome criteria must be identified (see Chapter 1 for more information on the nursing process and human need statements). In addition, outcomes must be realistic, based on patient human needs, stated in patient terms, and include behaviors that are measurable. Measureable terms include list, identify, demonstrate, self-administer, state, describe, and discuss. Implementation Related to Patient Education and Drug Therapy After you have completed the assessment phase, identified human need statements, and created a plan of care, the implementation phase of the teaching-learning process begins. This phase includes conveying specific information about the medication to the patient, family, or caregiver. The domain of learning (see previous discussion) must match the specific teaching method. Teaching methods/sessions must always accommodate the priorities of the patient. Teaching-learning sessions must incorporate clear, simple, concise written instructions (Box 6.4); oral instructions; and written pamphlets, pictures, videos, or any other learning aids that will help ensure patient learning. You may have to conduct several brief 325 teaching-learning sessions with multiple strategies, depending on the needs of the patient. Several changes related to the growth and aging of patients affect teaching-learning, and Table 6.1 lists educational strategies for accommodating these changes in a plan of care. You may also need to identify aids to help the patient in the safe administration of medications at home, such as the use of medication day or time calendars, pill reminder stickers, daily medication containers with alarms, weekly pill containers with separate compartments for different dosing times for each day for the week, and/or a method of documenting doses taken to avoid an overdosage or omission of doses. Box 6.4 National Council on Patient Information and Education: A Brief Review • The NCPIE, founded in 1982, is a nonprofit multi-stakeholder coalition working toward improving communication and information on appropriate medication use to consumers and health care professionals. • It is the leading authority for informing the general public and health care professionals on safe medication use through utilization of more effective communication leading to better health outcomes and quality of life. • NCPIE works diligently to address critical medicine safe-use issues, including adherence improvement, prescription drug overuse prevention, medication error reduction, and quality improvements in health care provider–patient medicine communication, and the safe storage or and disposal of medicines. • It develops and provides valuable patient educational programs and educational resources. • Some of NCPIE's public-facing websites include the following: www.talkaboutrx.org, www.bemedicinesmart.org, www.bemedwise.org, www.mustforseniors.org, and 326 www.recoveryopensdoors.org. • NCPIE's website, available at www.talkaboutrx.org, helps consumers make sound decisions about the use of medicines. Other resources available on NCPIE's website are Educate Before You Medicate: Knowledge Is the Best Medicine; Communicate Before You Medicate, Team Up and Talk, and Mustforseniors.org. • Some of the programs that have been launched include Talk About Your Medicines and Align My Refills, targeted towards the safe use/preventing abuse and medication safety. NCPIE, National Council on Patient Information and Education. Data from National Council on Patient Information and Education. (2015). National Council on Patient Information and Education website. Available at www.talkaboutrx.org. Accessed March 31, 2015. TABLE 6.1 Educational Strategies to Address Common Changes Related to Aging That May Influence Learning Change Related Educational Strategy to Aging Cognitive and Memory Impairment Slowed cognitive Slow the pace of the presentation, and attend to verbal and functioning nonverbal patient cues to verify understanding. New learning must relate to what the individual already knows; concrete and practical information presented with sensitivity and patience. Whenever possible, the readability and language used should be below the eighth-grade level—preferably at the fifth-grade level of English. Decreased short- Limit content to one or two objectives. Provide smaller term memory amounts of information at one time. Repeat information frequently. Provide written instructions for home use. Ask them to do, write, say, or show something to confirm their understanding. Decreased ability Use examples to illustrate information. Use a variety of to think abstractly methods, such as audiovisuals, props, videotapes, large-print materials, materials with vivid color, return demonstrations, and practice sessions. Decreased ability Decrease external stimuli as much as possible. Keep to concentrate communication short, and use simple sentences without 327 complex grammar. Keep handouts to one page, if at all possible. Increased reaction Always allow sufficient time, and be patient. Allow more time time (slower to for feedback. respond) Disturbed Sensory Perception Hearing Impairment Diminished Perform a baseline hearing assessment. Use tone- and volumehearing controlled teaching aids; use bright, large-print material to reinforce. Decreased ability Speak distinctly and slowly, and articulate carefully. to distinguish sounds (e.g., differentiate words beginning with S, Z, T, D, F, and G) Decreased Sit on the side of the patient's best ear. conduction of sound Loss of ability to Do not shout; speak in a normal voice but a lower voice pitch. hear highfrequency sounds Partial to Face the patient so that lip reading is possible. Use visual aids complete loss of to reinforce verbal instruction. Reinforce teaching with easy-tohearing read materials. Decrease extraneous noise. Use community resources for the hearing impaired. Visual Impairment Decreased visual Ensure that the patient's glasses are clean and in place and that acuity the prescription is current. Decreased ability Use printed materials with large print that is brightly and to read fine detail clearly colored. Print size needs to be fairly large (at least 14 points) if the older adult patient is using the materials at home. Decreased ability Use high-contrast materials, such as black on white. Avoid the to discriminate use of blue, violet, and green in type or graphics; use red among blue, instead. violet, and green; tendency for all colors to fade, with red fading the least Thickening and Use nonglare lighting, and avoid contrasts of light (e.g., a yellowing of the darkened room with a single light). lenses of the eyes, with decreased accommodation Decreased depth Adjust teaching to allow for the use of touch to gauge depth. perception 328 Decreased Keep all teaching materials within the patient's visual field. peripheral vision Touch and Vibration Impairment Decreased sense Increase the time allowed for the teaching of psychomotor of touch skills, the number of repetitions, and the number of return demonstrations. Decreased sense Teach the patient to palpate more prominent pulse sites (e.g., of vibration carotid and radial arteries). Modified from Touhy, T., Jett, K. (2017). Ebersole and Hess gerontological nursing and healthy aging (5th ed.). St Louis, MO: Mosby. Evidence-Based Practice A Drug by Any Other Name: Patients’ Ability to Identify Medication Regimens and Its Association With Adherence and Health Outcomes Review Understanding and organizing medication regimens are challenging to patients as well as to members of the health care team. With the increase in use of prescription as well as over-thecounter medications, preventing errors and enhancing patient safety with medication administration is a task that needs to be aggressively and consistently addressed. Many patients struggle daily to properly and safely self-administer prescribed medications. This struggle often leads to less effective treatment, more adverse effects, and/or patient harm. In addition, there are numerous generic prescription medications that sound alike and look alike. Generic prescriptions are prescribed more commonly due to economic reasons, thus adding further complexity to the picture. Patients often depend upon the familiarity of their “pill” or other dosage form, and often rely upon the shape and/or color of their “pill” to ensure accurate dosing. This form of medication identification combined with the variables of age, diversity, language barriers, and lack of proper education about the medication's characteristics, name, dosage, action, and indication leads to an increased potential for adverse drug events and poor 329 health outcomes. These issues with medication regimen may be the result of patients spending inadequate time discussing their medication regimen(s) or reconciling their medication with their health care providers. Methodology This study looked at the familiarity that patients diagnosed with hypertension possessed about their prescribed medication regimen. Specifically, they compared a group of patients and related knowledge about the names and dosages of their prescribed medications, compared with patients who relied upon only the physical characteristics of the medication(s) such as size, shape, and color. In particular, the association between patients’ self-reported regimen adherence, blood pressure control, and ability to identify their medications by name as compared to identification by visual characteristics was specifically explored. Other variables evaluated included specific patient attributes such as age, literacy skills, and comorbidity. Specific outcomes also evaluated included medication nonadherence, poor blood pressure control, and number of emergency room department visits and hospitalizations over the past year. Descriptive statistics with reporting of percentages, means, and standard deviation were calculated for demographic variables compared with how participants identified their medications (use of a one-way analysis of variance and chi-square). The outcomes of interest were also analyzed (see journal article for more specific information) as well as the risk ratio for each outcome of those identifying medications by physical appearance (or not at all) compared with those identifying the name of the medication, while also controlling for age, gender, race, health literacy, number of antihypertensive drugs taken, and comorbid conditions. Findings It was found that those patients who were dependent on physical (visual) characteristic identification of prescription medicine reported worse adherence. This group also had significantly lower rates of blood pressure control and greater risk for hospitalization. The ability to identify prescribed medicines by name may be helpful for screening and responding to patients at greater risk for 330 making medication errors or being less engaged with their regimen for adherence purposes. Those participants unable to identify their hypertension medications either by name or by appearance (44.8%) were more likely to miss taking a medication in the past week as compared to those who were able to identify by either name (22.5%) or appearance (21.8%). Participants identifying all medications by name tended to be less likely to have uncontrolled blood pressure, visit an emergency department, or be hospitalized in the past year, as compared with participants who were unable to identify medications by name. Those who were able to identify medication by appearance were more likely to have uncontrolled blood pressure and report being hospitalized in the past year compared with those who identified medications by name. Those who were unable to identify medications were also more likely to be hospitalized and were more likely to have missed a medication in the past week. It was also found that the ability to properly name medications was associated with health literacy. Application to Nursing Practice The findings of this study suggest that if a patient is unable to identify his or her antihypertensive medications by name, but only by physical characteristics, concerns are raised for patient outcomes of blood pressure control and health care utilization. These data also emphasize the need for attention during the medication reconciliation process to the accuracy of the medication list, but also to the patient's understanding of his or her medications. The results of this study, in particular, emphasize the need for more intensive efforts toward increased education with understanding and comprehension of medication regimens with attention to indications and safe use. Nursing can continue with more research on patients’ medical outcomes with their ability, or lack thereof, to identify their medications by name or physical characteristics. In addition, research on measures for increasing medication adherence and safety, or a combination of measures, may lead to better patient outcomes. Predictors of safety in medication self-management in all levels of health literacy are another important area of research. These data underscore the continued need for attention to the issue of the medication 331 reconciliation process to not only the accuracy of the medication list, but also to patients’ understanding of their medications. Patients will only benefit from more intensive efforts to improve their identification, understanding, and comprehension of their medication regimens. As nurses, we need to inquire about all medications the patient is taking, and even if they do know the name of the medication(s), knowing the correct dose and frequency is also critical to medication safety. From Lenahan, J. L., McCarthy, D. M., Davis, T. C., Curtis, L. M., Serper, M., & Wolf, M. S. (2013). A drug by any other name: patients’ ability to identify medication regimens and its association with adherence and health outcomes. Journal of Health Communication: International Perspectives, 18(1), 31–39. As the United States experiences increasing diversity and growth in minority populations, our nursing and health care system will continue to see a staggering increase in the percentage of non– English-speaking patients. Between 2014 and 2060, the population within the United States is expected to increase from 319 million to 417 million, reaching some 400 million in 2051. It is important to mention, however, that the US population is anticipated to grow more slowly in the future with the assumption of decreased fertility rates and a decline in international migration. It is expected, by 2044, more than half of all Americans will belong to a minority group (any group other than non-Hispanic white alone), and by 2060, it is projected that nearly one in five of the nation's total population will be foreign born. It is also anticipated that when the 2020 census is conducted, more than half the nation's children are expected to be part of a minority race or ethnic group. By 2044, it is projected that more than half of all Americans will belong to a minority group. The African American population is expected to increase by 14% by 2060; the Hispanic population is expected to increase from 55 million in 2014 to 119 million in 2060. Other minority groups are also expected to increase; the Asian population is expected to double to more than 9% of the total population, and the Native Hawaiian and Other Pacific Islander population is expected to increase by some 100% between 2014 and 2060 (Colby and Ortman, 2015). 332 This increasing diversity leads to more complex issues with communication, especially when the patient speaks limited or no English. Medical professionals are encouraged to communicate with the patient in the patient's native language, if proficient in that language. Joint Commission standards on language access have been instituted, and individuals with limited English proficiency have the right to what an English-speaking individual has when seeking health care services and/or health care information. Regardless of the situation, a credentialed interpretation professional needs to be an essential part of the health care team in order for the nurse and other members of the health care team to gain accurate and efficient insight into a patient's condition and needs. For the protection of patients and for health care providers, the individuals who are called upon need to be educated and certified in the language so that the appropriate message is conveyed. Interpreting is a profession with standards of practice, codes of ethics, and competency criteria. Just like with nursing and with every member of the health care team, interpreters must be properly trained, educated, and certified by an accredited body so that they can be trusted to communicate a patient's needs in order to achieve quality outcomes. In these types of patient scenarios, a qualified health care team includes the certified medical interpreter to facilitate the exchange between nurse/provider and patient. Family members need to be an active part of patient care, but in the situations of non–English-speaking patients, it is best for the patient and for quality outcomes to avoid the use of family members, laypersons, and nonprofessionals as interpreters. Certified medical interpreters are essential to avoiding problems with bias, misinterpretation, and potential confidentiality concerns. A welltrained, certified medical interpreter is an asset to the health care team and ensures quality patient outcomes in our non–Englishspeaking population. For more information, visit the following websites: the National Board for Certification of Medical Interpreters at www.certifiedinterpreters.org; the Certification Commission for Healthcare Interpreter Certification at www.healthcareinterpretercertifcation.org; and the National Board for Certification of Medical Interpreters at www.certifiedmedicalinterpreters.org. 333 Publications provided for non–English-speaking patients may enable you to convey a sufficient amount of information in the patient's language to help effectively educate the patient while also allowing you to share materials with family members and caregivers for their use. Companies now also publish a variety of patient education materials for the discharge teaching process in both English and Spanish. Providing resources to a non–Englishspeaking patient in his or her native language is important in making the patient feel safe in the environment and helps establish a therapeutic relationship, but this is not the same as interpreting. The teaching of manual skills for specific medication administration is also part of the teaching-learning session. Sufficient time must be allowed for the patient to become familiar with any equipment and to perform several return demonstrations to you or another health care provider. Teaching-learning needs will vary from patient to patient. Make every effort to include family members, significant others, or caregivers in the teaching session(s) for reinforcement purposes. Audiovisual aids may be incorporated and based on findings from the learning needs and nursing assessment. A reliable, academic reference resource of information about medications available to nurses and other health care professionals is the United States Pharmacopeia-National Formulary (USP-NF). The USP's drug standards are enforceable by the Food and Drug Administration (FDA), published and revised continuously by the United States Pharmacopeial Convention, and available in twice-yearly supplements. This resource is a book of pharmacopeial standards for chemical and biological drug substances, dosage forms, and compounded preparations, with separate monographs for dietary supplements. The USP-NF is available in English and Spanish and may serve as a valuable, reliable, and professional resource to use as a reference in preparation of teaching materials. It may be purchased individually; however, many health care facilities house these references in their medical libraries. Visit www.usp.org/uspnf/official-text for more information. Current nursing drug handbooks may also be beneficial for learning about specific medications and creating a patient teaching plan. In addition, visit www.ncbi.nlm.nih/gov for even more specific information about 334 patient outcomes as related to patient education and drug therapy. Always create a safe, nonthreatening, nondistracting environment for learning needs, and be open and receptive to the patient's questions. The following strategies may help ensure an effective teaching-learning session: • Begin the teaching-learning process upon the patient's admission to the health care setting (see the Teamwork and Collaboration: Legal and Ethical Principles box). • Individualize the teaching session to the patient. • Provide positive rewards or reinforcement (verbal affirmation) after accurate return demonstration of a procedure, technique, and/or skill during the teaching session. • Complete a medication calendar that includes the names of the drugs to be taken along with the dosage and frequency. • Use audiovisual and other learning aids that are specific to the patient. • Involve family members, significant others, or caregivers in the teaching session, as deemed appropriate. Keep the teaching on a level that is most meaningful to the given patient. Research has shown that 20% of the population reads at or below a fifth-grade level, with most health care materials written at a tenth-grade level. Materials written at a sixth-grade or lower reading level are recommended preferably with pictures, diagrams, and/or illustrations. Box 6.4 lists some general teaching and learning principles to consider in providing patient education. 335 Patient-Centered Care: Cultural Implications Patient Education Research various cultures to enhance an individualized approach to nursing care. For example, with Mexican American patients, aspects of nursing care must be approached in a sensitive manner with strong consideration for the family, communication needs, and religion. Approximately 90% of native Mexicans are Roman Catholic. To help meet the needs of these patients more effectively, consider speaking with them about their desire for clergy visits while in the hospital. Family members are generally involved, and Mexican Americans often have large extended families; therefore take the time to include family members in the patient's care and when providing discharge instructions and medication instructions. Health care professionals who work in a geographic area where a variety of non-English languages are widely spoken need to make an effort to learn one or more of these languages. Adult foreign language education is available in most US cities, often at 2and 4-year colleges or universities. Many classes are designed for working professionals and are scheduled at a variety of convenient times during the day and evening to accommodate demanding work schedules. Community colleges often offer quality courses that meet as little as 1 day or evening per week. Many employers will pay for job-related courses, and some courses may qualify for professional continuing education credits. Language courses provide a means of networking and developing quality friendships with other highly motivated, empathic individuals both within and outside of the health care profession. A variety of self-study materials are also available. However, interpreting is a profession with standards of practice, competency criteria, and codes of ethics. For a non–English-speaking patient, make sure you know the resources available to you in that particular health care setting. An interpreter is needed any time the patient and nurse do not speak the same language. Some of the common characteristics recommended for best- 336 practice interpreter services systems include the following: (1) 24hour access to oral language assistance for all limited–Englishproficient patients or non–English-speaking patients; (2) timely delivery of interpreter services for all languages; and (3) systematic and uniform assessment, training, and evaluation of competency across the various type of oral language assistance utilized. One option for provision of services is to have available trained medical interpreters or translators. Another option is the use of remote interpreting services, and many hospital settings have proven these services to be successful. Being culturally competent and sensitive is critical to quality patient care; however, effective communication for non–English-speaking patients is their right. Modified from Giger, J. N. (2013). Transcultural nursing: assessment and intervention (6th ed.). St. Louis, MO: Mosby. Teamwork and Collaboration: Legal and Ethical Principles Discharge Teaching The safest practices for discharge teaching are as follows: • Always follow the health care institution's policy on discharge teaching with regard to how much information to impart to the patient. • Do not assume that any patient has received adequate teaching before interacting with you. • Always begin discharge teaching as soon as possible when the patient is ready. • Minimize any distractions during the teaching session. • Evaluate any teaching of the patient and/or significant others by having the individuals repeat the instructions you have given them. • Contact the health care institution's social services department or the discharge planner if there are any concerns regarding 337 the learning capacity of the patient. • Written and/or verbal instructions for discharge medications should include information about the purpose of the drug(s), dosages and best timing for taking the medication(s), and side effects to report. • Utilize all resources available, such as interpreters, for patients speaking a different language from yourself. • Use the “teach back” method of teaching to ensure that the patient/family/significant others understand the at-home care plan and answer any questions. • Assist the patient in arranging appointments for follow-up and postdischarge testing with input from the patient, family, and/or significant others. • Document teaching-learning strategies used, such as videotapes and pamphlets. • Document what you taught, who was present with the patient during the teaching, what specific written instructions were given, what the responses of the patient and significant others or caregivers were, and what your own nursing actions were, such as specific demonstrations or referrals to community resources. Any follow-up teaching encounter also needs to be documented, with attention to reinforcement of information. Upon completion of any teaching-learning process or patient education session, documentation needs to include notes about the learner assessment, outcomes, content provided, strategies used, patient response to the teaching session, and an overall evaluation of learning. Because of the significance of patient education related to drug therapy and the nursing process, this textbook integrates patient education into each chapter in the implementation phase of the nursing process. In addition, a Patient-Centered Care: Patient Teaching section is included at the end of most chapters. Modified from RARE (Reducing Avoidable Readmissions Effectively). (2015). Available at www.rareadmissions.org. Accessed September 13, 2016. 338 Evaluation of Patient Learning Related to Drug Therapy Evaluation of learning outcomes needs to also be consistent with the identified domain of learning. Evaluation of patient learning is a critical component of safe and effective drug administration. To verify the success—or lack of success—of patient education, ask specific questions related to patient outcomes, and request that the patient repeat information or give a return demonstration of skills, if appropriate. The patient's behavior—such as adherence to the schedule for medication administration with few or no complications—is one key to determining whether or not teaching was successful and learning occurred. If a patient's behavior is characteristic of noncompliance or an inadequate level of learning, develop, implement, and evaluate a new plan of teaching. Case Study Patient-Centered Care: Patient Education and Anticoagulant Therapy © Supri Suharjoto. M.S., an 82-year-old retired librarian, has developed atrial fibrillation. As part of his medical therapy, he is started on the oral anticoagulant warfarin (Coumadin). His wife reports that he has some trouble hearing yet refuses to consider getting hearing aids. 339 In addition, this is his first illness, and his wife states that he has “always hated taking medications. He's read about herbs and folk healing and would rather try natural therapy.” The nurse is planning education about oral anticoagulant therapy, and M.S. says that he’ll “give it a try” for now, but he “knows nothing about this drug.” 1. What will the nurse assess, including possible barriers to learning, before teaching? 2. Formulate an education-related human needs statement for this patient based on the information given above. In addition, provide at least three examples of outcome criteria for the human need statement. 3. What education strategies will the nurse plan to use, considering any age-related changes the patient may have? Summary Patient education is a critical part of patient care, and patient education about medication administration, therapies, or regimens is no exception. From the time of initial contact with the patient throughout the time you work with the patient, the patient is entitled to all information about medications prescribed as well as other aspects of his or her care. Evaluation of patient learning and compliance with the medication regimen remains a continuous process; be willing to listen to the patient about any aspect of his or her drug therapy. Professional nurses are teachers and serve as patient advocates and thus have a responsibility to facilitate learning for patients, families, significant others, and caregivers. Accurate assessment of learning needs and readiness to learn always requires a look at the whole patient, including cultural values, health practices, and literacy issues. Every effort needs to be made to see that the patient receives effective learning to ensure successful outcomes with regard to drug therapy—and all parts of the patient's health care. It is important to consult the resources as the US Pharmacopeia (at http://www.usp.org), which serves as an advocate for patient safety and establishes standards for medications. This organization 340 is a tremendous resource for the health care professional in obtaining information for the patient so that quality patient education can be provided. The US Pharmacopeia values patient education as a means of enhancing patient safety as well as a means of decreasing medication errors in the hospital setting or at home. In addition, the Institute for Safe Medication Practices (at www.ismp.org) provides nurses with a wealth of information related to patient education, safety, and prevention of medication errors. As a nonprofit organization, this institute works closely with nurses, prescribers, regulatory agencies, and professional organizations to provide education about medication errors and their prevention, and is a premier resource in all matters pertaining to safe medication practices in health care organizations. Another resource is the National Council on Patient Information and Education (NCPIE), which may be accessed at http://www.talkaboutrx.org. This site was developed with the purpose of stimulating and improving communication of information on the appropriate use of medications to consumers and health care professionals (see Box 6.4). Centerwatch.com is a site providing information and views on the clinical trials industry. A PDF reprint can be obtained from this online resource. In summary, professional nurses usually have the most contact with patients and see patients in a variety of settings. Because of this, nurses need to continue to be patient advocates and take the initiative to plan, design, create, and present educational materials for teaching about drug therapy. Patient-Centered Care: Patient Teaching • Teaching needs to focus on either the cognitive, affective, or psychomotor domain, or a combination of all three. The cognitive domain may involve recall for synthesis of facts, with the affective domain involving behaviors such as responding, valuing, and organizing. The psychomotor domain includes teaching someone how to perform a procedure. • Realistic patient teaching outcomes must be identified and 341 established with the involvement of the patient, caregiver, or significant other. • Keep patient teaching on a level that is most meaningful to the individual. Most research indicates that reading materials need to be written at a sixth-grade reading level or lower but may be adjusted accordingly to patient assessment. • Follow teaching and learning principles when developing and implementing patient education. • Discuss basic information such as brand/generic name, drug action and function in the body, specific regimen (e.g., dosage, timing), possible side effects, drug interactions, foods/liquids/activities to avoid while on the medication, safe storage of the medication, safe disposal of unused medication, and refills. • Encourage patients to update a listing of all medications and allergies and keep it on their person at all times. • Be sure to control the environmental factors, such as lighting, noise, privacy, and odors. Provide dignified care while preparing the patient for teaching, and respect personal space. If there are distractions, such as television, radio, cell phone, or computer, work with the patient/family members to safely and appropriately quiet these items during teaching sessions. • Make sure that all patient education materials are organized and at hand. If the patient wears eyeglasses or hearing aids, be sure they are made available prior to education. Key Points • The effectiveness of patient education relies on an understanding of and attention to the cognitive, affective, and psychomotor domains of learning. After you have completed the assessment phase, identified human need statements, and created a plan of care, the 342 implementation phase of the teaching-learning process begins; reevaluation of the teaching plan must occur frequently and as needed. The growth in cultural diversity, in particular the increase in the Hispanic population, demands that nursing and related health care professions provide patient education materials in both English and Spanish. • In educational sessions, patients need to receive information through as many senses as possible, such as verbally and visually (e.g., through pamphlets, videotapes, and diagrams), to maximize learning. Information must be presented at the patient's reading level (in the patient's native language, if possible) and suitable for the patient's level of cognitive development. • Teaching and learning principles also must be integrated into patient education plans. Evaluation of patient learning is a critical component of safe and effective drug administration. • To verify the success—or lack of success—of patient education, nurses need to be very specific in their questions related to patient outcomes and request that the patient repeat information or perform a return demonstration of skills, if appropriate. • Be knowledgeable about all available resources for non–English-speaking patients, including the use of certified medical interpreters. Critical Thinking Exercises 343 1. A nurse has been trying to communicate with a patient who does not speak English, but so far none of the communication techniques has been successful. What are the best strategies the nurse can use to develop a plan of care that addresses patient teaching? 2. A patient has had hip replacement surgery and will be going home in a few days. The surgeon has requested that the nurses teach the patient and a family member how to give subcutaneous injections of the low– molecular-weight heparin that will be prescribed for him after his discharge. What is the priority regarding this patient's education? Explain your answer. Review Questions 1. A 47-year-old patient with diabetes is being discharged to home and must take insulin injections twice a day. The nurse keeps in mind which concepts when considering patient teaching? a. Teaching needs to begin at the time of diagnosis or admission and is individualized to the patient's reading level. b. The nurse can assume that because the patient is in his forties he will be able to read any written or printed documents provided. c. The majority of teaching can be done with pamphlets that the patient can share with family members. d. A thorough and comprehensive teaching plan designed for an eleventh-grade reading level needs to be developed. 2. The nurse is developing a teaching plan for a patient with a new diagnosis of type I diabetes mellitus. Which 344 of these outcome statements are appropriate? (Select all that apply.) a. The patient will list three signs and symptoms of hypoglycemia. b. The patient will demonstrate how to self-administer an insulin injection with an insulin pen. c. The patient will know about type I diabetes mellitus. d. The patient will describe steps to take in case of hypoglycemia. e. The patient will agree to check his blood glucose levels three times a day. 3. The nurse is responsible for preoperative teaching for a patient who is mildly anxious about receiving pain medications postoperatively. The nurse recognizes that this level of anxiety in the patient may result in which of these? a. Impeded learning because anxiety is always a barrier to learning b. Major emotional instability c. Increased motivation to learn d. Increased postoperative healing time 4. What action by the nurse is the best way to assess a patient's learning needs? a. Quiz the patient daily on all medications. b. Begin with validation of the patient's present level of knowledge. c. Assess family members’ knowledge of the prescribed medication even if they are not involved in the patient's care. d. Ask the caregivers what the patient knows about the 345 medications. 5. Which technique would be most appropriate to use when the nurse is teaching a patient with a language barrier? a. Obtain an interpreter who can speak in the patient's native tongue for teaching sessions. b. Use detailed explanations, speaking slowly and clearly. c. Assume that the patient understands the information presented if the patient has no questions. d. Provide only written instructions. 6. A nursing student is identifying situations that involve the psychomotor domain of learning as part of a class project. Which are examples of learning activities that involve the psychomotor domain? (Select all that apply.) a. Teaching a patient how to self-administer eye drops b. Having a patient list the adverse effects of an antihypertensive drug c. Discussing what foods to avoid while taking antilipemic drugs d. Teaching a patient how to measure the pulse before taking a beta blocker e. Teaching a family member how to give an injection f. Teaching a patient the rationale for checking a drug's blood level 7. The nurse is instructing an older adult patient on how to use his walker. Which education strategies are appropriate? (Select all that apply.) a. Speak slowly and loudly. b. Ensure a quiet environment for learning. 346 c. Repeat information frequently. d. Allow for an increased number of return demonstrations. e. Provide all the information in one teaching session. 8. You are reviewing newly prescribed medications with the wife of a patient who will be discharged today on a liquid diet after jaw surgery. She will be giving the patient his medications. There is a prescription for liquid metoclopramide (Reglan), 10 mg PO before breakfast and dinner. The medication is available in a strength of 5 mg/mL. How many mL will she need to give for each dose? References 10 Elements of competence for using teach-back effectively. [Available at] www.teachbacktraining.org/assets/files/PDFS/Teach%20Back %2010%20Elements%20of%20Competence.pdf. Alfaro-Lefevre R. Critical thinking and clinical judgment: a practical approach to outcome-focused thinking. 5th ed. Elsevier Saunders: St Louis, MO; 2013. American Nurses Association. Nursing: scope and standards of practice. American Nurses Association: Silver Spring, MD; 2004. Billings DM. Teaching in nursing: a guide for faculty. 5th ed. Elsevier Saunders: St Louis, MO; 2016. Canobbio MM. Mosby's handbook of patient teaching. 3rd ed. Mosby: St Louis, MO; 2006. Chang M, Kelly AE. Patient education: addressing cultural diversity and health literacy issues. 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[Cleveland, OH; The Center for Healthcare Communication; Available at] www.communicatingwithpatients.com/articles/teaching_abo 2010. Lenahan JL, McCarthy DM, Davis TC, et al. A drug by any other name: patients’ ability to identify medication regimens and its association with adherence and health outcomes. J Health Commun. 2013;18(1):31–39. National Adult Education Professional Development Consortium. National assessment of adult literacy. 348 [Available at] http://www.naepdc.org/about_NAEPDC/NAAL.html 2005. National Council on Patient Information and Education (NCPIE). National Council on Patient Information and Education website. [Available at] www.talkaboutrx.org; 2015. Negley DF, Ness S, Fee-Schroeder K, et al. Building a collaborative nursing practice to promote patie education: an inpatient and outpatient partnership. Oncology Nursing Forum. 2009;36(1):19–23. Nies MA. Community/public health nursing: promoting the health of populations. 5th ed. 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[Available at] www.healthypeople.gov; 2014. 350 7 Over-the-Counter Drugs and Herbal and Dietary Supplements OBJECTIVES When you reach the end of this chapter, you will be able to do the following: 1. Discuss the differences between prescription drugs, over-the-counter (OTC) drugs, herbals, and dietary supplements. 2. Briefly discuss the differences between the federal legislation governing the promotion and sale of prescription drugs and the legislation governing OTC drugs, herbals, and dietary supplements. 3. Describe the advantages and disadvantages of the use of OTC drugs, herbals, and dietary supplements. 4. Discuss the role of nonprescription drugs, specifically herbals and dietary supplements, in the integrative (often called alternative or complementary) approach to nursing and health care. 5. Discuss the potential dangers associated with the use of OTC drugs, 351 herbals, and dietary supplements. 6. Develop a nursing care plan related to OTC, herbal, and dietary supplement drug therapy and the nursing process. KEY TERMS Alternative medicine Herbal medicine, chiropractic, acupuncture, massage, reflexology, and any other therapies traditionally not emphasized in Western medical schools. Complementary medicine Alternative medicine when used simultaneously with, rather than instead of, standard Western medicine. Conventional medicine The practice of medicine as taught in Western medical schools. Dietary supplement A product that contains an ingredient intended to supplement the diet, including vitamins, minerals, herbs, or other botanicals. Herbal medicine The practice of using herbs to heal. Herbs Plant components including bark, roots, leaves, seeds, flowers, fruit of trees, and extracts of these plants that are valued for their savory, aromatic, or medicinal qualities. Iatrogenic effects Unintentional adverse effects that are caused by the actions of a prescriber or other health care professional, or by a specific treatment. Integrative medicine Simultaneous use of both traditional and alternative medicine. Legend drugs Medications that are not legally available without a prescription from a prescriber; also called prescription drugs. Over-the-counter (OTC) drugs Medications that are legally available without a prescription. 352 Phytochemicals The pharmacologically active ingredients in herbal remedies. Over-the-Counter Drugs Health care consumers are becoming increasingly involved in the diagnosis and treatment of common ailments. This has led to a great increase in the use of nonprescription or over-the-counter (OTC) drugs. More than 80 classes of OTC drugs are marketed to treat a variety of illnesses, ranging from acne to cough and cold, pain relief, and weight control. There are currently more than 300,000 OTC products containing over 800 major active ingredients. Health care consumers use OTC drugs to treat or cure more than 400 different ailments. Over 40 medications that formerly required a prescription are now available OTC. Large numbers of older adults (40% to 48%) use one OTC product regularly. Some of the most commonly used OTC products, such as acetaminophen, aspirin, ibuprofen, famotidine, antacids, loperamide, and cough and cold products, are discussed in other chapters and are listed in Table 7.1. TABLE 7.1 Common Over-the-Counter Drugs Type of OTC Drug Acid-controlling drugs (H2 blockers), antacids, and proton pump inhibitors Antifungal drugs (topical) Antihistamines and decongestants Examples famotidine (Pepcid AC), ranitidine (Zantac); aluminum- and magnesium-containing products (Maalox, Mylanta); calcium-containing products (Tums), esomeprazole (Nexium 24), lansoprazole (Prevacid-24), omeprazole (Prilosec-OTC) clotrimazole (Lotrimin), miconazole (Monistat), terbinafine (Lamisil AT) brompheniramine (Dimetapp), cetirizine (Zyrtec), chlorpheniramine (Theraflu), diphenhydramine (Benadryl), fexofenadine (Allegra), guaifenesin (Robitussin), loratadine (Claritin), pseudoephedrine (Sudafed) 353 Where Discussed in This Book Chapter 50 Chapter 56 Chapter 36 Eyedrops artificial tears (Moisture Eyes) Hair growth drugs (topical) Pain-relieving drugs Analgesics minoxidil (Rogaine) Chapter 57 Chapter 56 acetaminophen (Tylenol) Chapter 10 Nonsteroidal aspirin, ibuprofen (Advil, Motrin), naproxen sodium Chapter antiinflammatory (Aleve) 44 drugs Nasal steroids fluticasone (Flonase), triamcinolone (Nasacort) Chapter 33 Smoking transdermal nicotine patches, nicotine gum Chapter deterrents 17 OTC, Over-the-counter. In 1972, the US Food and Drug Administration (FDA) initiated an OTC Drug Review to ensure the safety and effectiveness of the OTC products available, as well as to establish appropriate labeling standards. As a result of this review, approximately one-third of the OTC products were determined to be safe and effective for their intended uses, and one-third were found to be ineffective. A small number were considered to be unsafe, and the remainder required submission of additional data. Products determined to be unsafe were removed from the market. Some established products that were found to be ineffective but not unsafe were “grandfathered” in and allowed to remain on the market. Many of these have gradually slipped into obscurity and are no longer sold. The FDA now requires new stricter “drug facts” labeling for OTC products that includes information on the following: purpose and uses of the product; specific warnings, including when the product should not be used under any circumstances; and when it is appropriate to consult a doctor or pharmacist. This labeling also describes side effects that could occur; substances or activities to avoid; dosage instructions; and active ingredients, warnings, storage information, and inactive ingredients. More than 40 medications that were previously available by prescription only have been reclassified to OTC status. A drug must meet the criteria listed in Box 7.1 to be considered for reclassification. The required information is obtained from clinical 354 trials and postmarketing safety surveillance data, which are submitted to the FDA by the manufacturer. Although this reclassification procedure has been criticized as overly timeconsuming, it is structured to ensure that products reclassified to OTC status are safe and effective when used by the average consumer. Box 7.1 Criteria for Over-the-Counter Status Indication for Use Consumer must be able to easily: • Diagnose condition • Monitor effectiveness Benefits of correct usage must outweigh risks. Safety Profile Drugs must have: • Favorable adverse event profile • Limited interaction with other drugs • Low potential for abuse • High therapeutic indexa Practicality for Over-the-Counter Use Drugs must be: • Easy to use • Easy to monitor aRatio of toxic to therapeutic dosage. 355 OTC status has many advantages over prescription status. Patients can conveniently and effectively self-treat many minor ailments. Some professionals argue that allowing patients to selftreat minor illnesses enables prescribers to spend more time caring for patients with serious health problems. Others argue that it delays patients from seeking medical care until they are very ill. Reclassification of a prescription drug as an OTC drug may increase out-of-pocket costs for many patients because third-party health insurance payers usually do not cover OTC products. However, overall health care costs tend to decrease when products are reclassified as OTC due to a direct reduction in drug costs, elimination of prescriber office visits, and avoidance of pharmacy dispensing fees. Some examples of drugs that have recently been reclassified as OTC products appear in Box 7.2. Box 7.2 Selected Reclassified Over-the-Counter Products Analgesics Ibuprofen (Advil, Motrin) Naproxen sodium (Aleve, Naprosyn) Histamine Blockers H1 Receptors Chlorpheniramine maleate (Chlor-Trimeton) Diphenhydramine hydrochloride (Benadryl) Fexofenadine (Allegra) Loratadine (Claritin) Cetirizine (Zyrtec) H2 Receptors 356 Cimetidine (Tagamet HB) Famotidine (Pepcid AC) Nizatidine (Axid AR) Ranitidine (Zantac) Nasal Steroids Flonase Allergy Relief (fluticasone propionate) Nasacort Allergy 24 HR (triamcinolone acetonide) Proton Pump Inhibitors Esomeprazole (Nexium-24) Lansoprazole (Prevacid-24) Omeprazole (Prilosec-OTC) Smoking Deterrents Nicotine polacrilex gum (Nicorette) Nicotine transdermal patches (Nicoderm) (other dosage forms available) Topical Medications Clotrimazole (Lotrimin) Butoconazole (Femstat) Miconazole (Monistat) Minoxidil solution and hydrocortisone acetate 1% cream (Rogaine) Terbinafine (Lamisil AT) Weight Loss Products Orlistat (AllÄ«) For more information, see www.consumermedsafety.org/tools-andresources/medication-safety-tools-and-resources/consumer-medsafetylists/item/601-ten-tips-for-measuring-over-the-counter-liquid-medications- 357 safely. Accessed February 19, 2017. The importance of patient education cannot be overstated. Many patients are inexperienced in the interpretation of medication labels (Fig. 7.1), which results in misuse of the products. This lack of experience and possibly a lack of knowledge may lead to adverse events or drug interactions with prescription medications or other OTC medications. Small print on OTC package labels often complicates the situation, especially for older adults. According to a report by the Institute for Safe Medication Practices (ISMP), parents gave children incorrect doses of OTC fever medications more than 50% of the time. Use of OTC medications can be hazardous for patients with various chronic illnesses, including diabetes, hypertension, cardiovascular disease, and glaucoma. Patients are encouraged to read labels carefully and consult a qualified health care professional when in doubt. FIG. 7.1 Example of an over-the-counter drug label. (From US Food and Drug Administration. [2017]. The new overthe-counter medicine label: Take a look. Available at www.fda.gov/Drugs/EmergencyPreparedness/BioterrorismandDrugPreparedness/ucm133411 358 oVxzZyo.email. Accessed August 29, 2016.) OTC medications may relieve symptoms without necessarily addressing the cause of the disorder; this can cause delay in the effective management of chronic disease states or treatment of serious and/or life-threatening disorders. OTC medications also have their own toxicity profiles. In 2008, the FDA issued recommendations that OTC cough and cold products not be used in children younger than 2 years of age. This followed numerous case reports of symptoms such as oversedation, seizures, tachycardia, and even death in toddlers medicated with such products. There is also evidence that such medications are simply not efficacious in small children. A follow-up study showed a dramatic decrease in young children's emergency department visits since the FDA recommendation (Shehab et al., 2010). Parents are advised to be mindful of how much medication they give and to be careful not to give two products that contain the same active ingredient(s). Two other examples of OTC drug hazards include products containing acetaminophen (e.g., Tylenol) and nonsteroidal antiinflammatory drugs (NSAIDs) such as ibuprofen (e.g., Advil, Motrin) and naproxen (e.g., Aleve). Liver toxicity is associated with excessive doses of acetaminophen and is a leading cause of liver failure. Acetaminophen doses are not to exceed a total of 3 to 4 g/day. The use of NSAIDs is associated with gastrointestinal ulceration, kidney dysfunction, myocardial infarction, and stroke. Patients may take excessive dosages of these and other OTC medications. In 2009, the FDA began requiring specific labeling for acetaminophen, aspirin, and NSAIDs to enhance consumer awareness of these risks. Abuse can also be a potential hazard with the use of OTC drug products. Pseudoephedrine is found in a variety of cough and cold products (see Chapter 36); however, this drug is also used to manufacture the widely abused street drug methamphetamine. Because of the potential for abuse, products containing pseudoephedrine must be sold from behind the pharmacy counter. Many patients become addicted to OTC nasal sprays because they can cause rebound congestion and dependency. Dextromethorphan 359 (used as a cough suppressant) is also commonly abused. It is known by the brand name of Robitussin, and abusing it is called Robotripping. Several other OTC products can cause specific problems. The use of sympathomimetics (see Chapter 18) can cause problems in patients with type 1 diabetes and patients with hypertension or angina. Aspirin is not to be used in children as it can cause a rare condition called Reye syndrome (see Chapter 44). Long-term use of antacids can result in constipation or impaction (see Chapter 50). Normally OTC medications are used only for short-term treatment of common minor illnesses. An appropriate medical evaluation is recommended for all chronic health conditions, even if the final decision is to prescribe OTC medications. Patient assessment includes questions regarding OTC drug use, including questions about conditions undergoing treatment. Such questions may also help uncover more serious medical problems. Inform patients that OTC drugs, including herbal products, are still medications. Their use may have associated risks depending on the specific OTC drugs used, concurrent prescription medications, and the patient's overall health status and disease states. Health care professionals have an excellent opportunity to prevent common problems associated with the use of OTC drugs, as over 50% of patients consult a health care professional when selecting an OTC product. Provide patients with information about choice of an appropriate product, correct dosing, common adverse effects, and drug interactions. For specific information on various OTC drugs, see the appropriate drug chapters later in this text (see Table 7.1 for crossreferences to these chapters). Herbals and Dietary Supplements History Dietary supplement is a broad term for orally administered alternative medicines and includes the category of herbal supplements. Dietary supplements are products that are intended to augment the diet and include vitamins, minerals, herbs or other 360 botanicals, amino acids, and enzymes. Dietary supplements may be produced in many forms, such as tablets, capsules, liquids, and powders. These supplements may also be found in nutritional, breakfast, snack, or health food bars; drinks; and shakes. Herbs come from nature and have been used for thousands of years to help maintain good health. About 30% of all modern drugs are derived from plants (Table 7.2). In the early 19th century, scientific methods became more advanced and became the preferred means of healing. At this time, the practice of botanical healing was dismissed as quackery. Herbal medicine lost ground to new synthetic medicines during the early part of the 20th century. In the 1960s, concerns were expressed over the iatrogenic effects of conventional medicine. These concerns, along with a desire for more self-reliance, led to a renewed interest in “natural health,” and, as a result, the use of herbal products increased. In 1974, the World Health Organization encouraged developing countries to use traditional plant medicines. In 1978, the German equivalent of the FDA published a series of herbal recommendations known as the Commission E monographs. These monographs focus on herbs whose effectiveness for specific indications is supported by the research literature. Recognition of the increasing use of herbal products and alternative medicine led to the establishment of the Office of Alternative Medicine by the National Institutes of Health in 1992. This office was later renamed the National Center for Complementary and Alternative Medicine (NCCAM). Complementary medicine refers to the simultaneous use of both traditional and alternative medicine. This practice is also referred to as integrative medicine. NCCAM classifies complementary and alternative medicine into the following five categories: (1) alternative medical systems, (2) mind-body interventions, (3) biologically based therapies, (4) manipulative and body-based methods, and (5) energy therapies. TABLE 7.2 Conventional Medicines Derived From Plants Medicinea Atropine Plant Atropa belladonna 361 Capsaicin Cocaine Codeine Digoxin Paclitaxel Scopolamine Senna Vincristine a Capsicum frutescens Erythroxylon coca Papaver somniferum Digitalis lanata Taxis brevifolia Datura fastuosa Cassia acutifolia Catharanthusroseus Includes both over-the-counter and prescription drugs. Many controversies remain about the safety and control of herbals and dietary supplements. Their uses and touted advantages are widely publicized. As a result, these products are sold in grocery stores, pharmacies, health food stores, and fitness gyms and can even be ordered through television, radio, and the Internet. Adverse effects are considered to be minimal by the public as well as by the companies that sell these supplements. However, a false sense of security has been created because the view of the public tends to be that if a product is “natural,” then it is safe. The information listed in this textbook regarding herbal products does not imply author or publisher endorsement of such products. For many years, neither federal legislation nor the FDA provided any safeguards surrounding dietary supplements. Instead, manufacturers were responsible only for ensuring product safety. In 1993, the FDA threatened to remove dietary supplements from the market. The American public reacted with a massive letterwriting campaign to Congress, and the 103rd Congress responded by passing the Dietary Supplement and Health Education Act (DSHEA) of 1994. The DSHEA defined dietary supplements and provided a regulatory framework. In 2002, the US Pharmacopeia, an independent organization that is the government's official standard-setting authority for dietary supplements, began certifying products that it had independently tested as part of its Dietary Supplement Verification Program. A major difference between legend drugs (prescription drugs) and OTC products and dietary supplements is that the DSHEA requires no proof of efficacy and sets no standards for quality control for supplements. In contrast, the FDA has specific and stringent requirements for manufacturers of legend drugs. However, in June 2007, the FDA announced that all manufacturers 362 of dietary supplements would be required to comply with the same good manufacturing practices as prescription manufacturers. Under these new requirements, manufacturers must provide data that demonstrate product identity, composition, quality, purity, and strength of active ingredients. They must also demonstrate that products are free from contaminants such as microbes, pesticides, and heavy metals. Manufacturers of supplements may currently claim an effect but cannot promise a specific cure on the product label. Dietary supplements do not need approval from the FDA before they are marketed. The FDA posts warnings on herbal products on its website (www.fda.gov). Regulating agencies in Germany, France, the United Kingdom, and Canada require manufacturers to meet standards of herbal quality and safety. Consumer Use of Dietary Supplements Consumer use of dietary supplements is growing, with an estimated 63% of US adults using some form of alternative medicine. Consumers use dietary supplements for the treatment and prevention of diseases and proactively to preserve health and wellness and boost the immune system. In addition, herbs may be used as adjunct therapy to support conventional pharmaceutical therapies. Some herbal products may be used to treat minor conditions and illnesses (e.g., coughs, colds, stomach upset) in much the same way that conventional FDA-approved, OTC nonprescription drugs are used. Safety Dietary supplements, and especially herbal medicines, are often perceived as being natural and therefore harmless; however, this is not the case. Many examples exist of allergic reactions, toxic reactions, and adverse effects caused by herbs. Some herbs have been shown to have possible mutagenic effects and to interact with drugs (Table 7.3). It is estimated that more than 40% of patients using dietary supplements do not disclose this to their health care providers. In addition, one study identified a relatively low level of knowledge of these products and their risks, even among regular 363 users. This demonstrates the need for health care providers to develop a clinical knowledge base regarding these products and know where to find key information as the need arises. Because of underreporting, present knowledge may represent but a small fraction of potential safety concerns. Also, the FDA has limited oversight of how dietary supplements are prepared, whether herbal or not. TABLE 7.3 Selected Herbs and Dietary Supplements and Their Possible Drug Interactions Herb or Dietary Supplement Chamomile Cranberry Echinacea Evening primrose Garlic Gingko Ginger root Grapefruit Hawthorn Kava Saw palmetto St. John's wort Valerian Possible Drug Interaction Increased risk for bleeding with anticoagulants Decreased elimination of many drugs that are renally excreted Possible interference with or counteraction to immunosuppressant drugs and antivirals Possible interaction with antipsychotic drugs Possible interference with hypoglycemic therapy and the anticoagulant warfarin (Coumadin) May increase risk for bleeding with anticoagulants (warfarin, heparin) and antiplatelets (aspirin, clopidogrel) At high dosages, possible interference with cardiac, antidiabetic, or anticoagulant drugs Decreases metabolism of drugs used for erectile dysfunction, estrogens, and some psychotherapeutic drugs. Increases risk for toxicity of immunosuppressants, HMG-CoA reductase inhibitors, and some psychotherapeutic drugs Increases intensity and duration of effects of caffeine May lead to toxic levels of cardiac glycosides (e.g., digitalis) May increase the effect of barbiturates and alcohol May change the effects of hormones in oral contraceptive drugs, patches, or hormonal replacement therapies May lead to serotonin syndrome if used with other serotonergic drugs (e.g., selective serotonin reuptake inhibitors [see Chapter 16]). May interact with many drugs, including antidepressants, antihistamines, digoxin, immunosuppressants, theophylline, and warfarin. Increases central nervous system depression if used with sedatives There are few published scientific data regarding the safety of 364 dietary supplements. Two recent examples indicating some of the growing concerns about herbal remedies include the FDA warnings about possible liver toxicity with the use of kava and possible cardiovascular and stroke risks with the use of ephedra. The sale of ephedra was officially banned by the FDA in April 2004. Kava remains on the market despite a 2002 FDA consumer-warning letter regarding the risk for liver toxicity. Also, a state-of-the-art paper published in the Journal of the American College of Cardiology in 2010 suggests that many herbal products are best avoided in patients with cardiovascular diseases (Tachjian et al., 2010). Herbal products can increase bleeding risk with warfarin (see Chapter 26), potentiate digoxin toxicity (see Chapter 24), increase the effects of antihypertensive agents (see Chapter 22), and cause heart block or dysrhythmias (see Chapter 25). Consumers are encouraged to report adverse effects to the FDA's MedWatch (800-332-1088). Other authoritative references that can be utilized for herbal information include Pharmacist's Letter/Prescriber's Letter Natural Medicines Comprehensive Database and Natural Standard, available at www.naturalstandard.com. Level of Use Estimates of the prevalence of dietary supplement use differ greatly. The wide disparity in these estimates is most likely due to the use of varying terminology (e.g., “herbs” versus “dietary supplements”). The FDA estimates that more than 29,000 different dietary supplements are currently used in the United States, with approximately 1000 new products introduced annually. One recent estimate of the amount spent on dietary supplements was in excess of $6.4 billion annually in the United States. The use of botanical medicines is greater in other parts of the world than in the United States. Herbal medicine is based on the premise that plants contain natural substances that can promote health and alleviate illness. The many different herbs in these preparations contain a wide variety of active phytochemicals (plant compounds). Some of the more common ailments and conditions treated with herbs are 365 anxiety, arthritis, colds, constipation, cough, depression, fever, headache, infection, insomnia, intestinal disorders, premenstrual syndrome, menopausal symptoms, stress, ulcers, and weakness. Herbal products constitute the largest growth area in retail pharmacy. Insurance plans and managed care organizations are beginning to offer reimbursement for alternative treatments. Some of the most commonly used herbal remedies are aloe, black cohosh, chamomile, echinacea, feverfew, garlic, ginger, ginkgo biloba, ginseng, goldenseal, hawthorn, St. John's wort, saw palmetto, and valerian. These products are covered in more detail in the Safety: Herbal Therapies and Dietary Supplements boxes that appear in the various drug chapters (see the inside back cover for a complete listing of these boxes with page numbers throughout the textbook). Nursing Process Assessment Over-the-Counter Drugs Nursing assessments are always important to perform, but they are especially important when a patient is self-medicating. Previous use of OTC drugs and the patient's response are important to note. Successes versus failures with drug therapies and self-medication, reading level, cognitive and developmental level, and motor abilities are other variables to sssess. Patient-Centered Care: Cultural Implications Drug Responses and Cultural Factors Responses to drugs—including over-the-counter (OTC) drugs, herbals, and dietary supplements—may be affected by beliefs, values, and genetics as well as by culture, race, and ethnicity (see Chapter 4 for more discussion of cultural considerations). An example of the impact of culture on drug response and use relates 366 to Japanese patients and if they are experiencing nausea, vomiting, or bowel changes as adverse effects of OTC drugs, herbals, and/or dietary supplements. The reason is that the Japanese culture finds it unacceptable to complain about gastrointestinal symptoms, and so these symptoms may go unreported to the point of causing risk to the patient. Herbal and alternative therapies may be used more extensively in some cultures when compared with other cultures. Wide acceptance of herbal use without major concern for the effects on other therapies may be very problematic because of the many interactions of conventional drugs with herbals and dietary supplements. For example, the Chinese herb ginseng may inhibit or accelerate the metabolism of a specific medication and significantly affect the drug's absorption or elimination. One genetic factor that has an influence on drug response is acetylation polymorphism—that is, prescription drugs, OTC drugs, herbals, and dietary supplements may be metabolized in different ways that are genetically determined and vary with race or ethnicity. For example, populations of European or African descent contain approximately equal numbers of individuals showing rapid and slow acetylation (which affects drug metabolism), whereas Japanese and Inuit populations may contain more rapid acetylators. Race has also been linked to variability in the dosing of warfarin in the process of anticoagulation, with African Americans requiring higher doses and the Asian population requiring lower doses when compared with whites. Intrinsic factors such as genetics and metabolism and extrinsic factors such as diet, sociocultural issues, and environmental exposure are notable in that whites are more likely to have abnormally low levels of the metabolic enzyme CYP2D6, leading to variability in therapeutic drug levels of antidepressants, antipsychotics, and beta blockers. Blacks have shown to respond poorly to beta-blockers and angiotensin-converting enzyme (ACE) inhibitors. There have also been studies reporting that there are racial differences in skin structures that may then affect responses to dermatologic and topically applied drugs. 367 From Yasuda, S. U., Zhang, L., Huang, S. M. (2008). The role of ethnicity in variability in response to drugs: focus on clinical pharmacology studies. Clinical Pharmacology and Therapeutics, 84(3), 417–423. Other assessment data include questioning about allergies to any of the ingredients of the drug. Include a list of all medications and substances used by the patient, including OTC drugs, prescription drugs, herbal products, vitamins, and minerals in the medication history. Also note use of alcohol, tobacco, and caffeine. Assess past and present medical history so that possible drug interactions, contraindications, and cautions are identified. Screen patients carefully before recommending an OTC drug because patients often assume that if a drug is sold OTC it is completely safe to take and without negative consequences. This is not true—OTC drugs can be just as lethal or problematic as prescription drugs if they are not taken properly or are taken in high dosages and without regard to directions (see discussion earlier in the chapter). Safety and Quality Improvement: Preventing Medication Errors Measuring Over-the-Counter Liquid Medications Safely • Never use household measuring devices (teaspoons, etc.) to give liquid medicines. They are inaccurate and may deliver more or less than prescribed. Today’s over-the-counter (OTC) liquid medicines are almost always accompanied with their own measuring devices. • Use only the device that comes with the OTC medicine, such as an oral syringe or a dosing cup. These are calibrated to match the specific product labelling. In the event a dosing device does not come with the product, ask a pharmacist to recommend one. • When administering OTC liquids to a child, be sure to know 368 the child’s current weight. To get the most accurate dose, it’s best to dose according to weight, not age. Tables are often present on the product label to help guide proper dosing by weight. • Never read container labels or measure liquid medicines in a dimly lit or dark room or when you are distracted. • When measuring the liquid medicine with a dosing cup, always be sure to look at it at eye level. Measure on a flat surface and not while holding in one hand. You may need to lower yourself to read the liquid volume. •. • After measuring liquid medicine, immediately replace the cap. If small children either live in your home, or will be visiting, be sure child-resistant caps are always locked into place. • Always be sure to wash the dosing device after giving the medicine. If you fail to do so, bacteria can grow and cause contamination with any future use. • It’s best to store both the medicine and dosing tool together. An oral syringe can be rubber banded or a dosing cup can usually be placed over the cap. This way, you will always have the correct measuring device on hand when you need it. Never use a device supplied with one medicine for a different medicine. This can lead to dosing errors. • Always store adult and child preparations of liquid medicines in separate areas. This will decrease the chance of accidentally confusing the containers with one another. For more information, see www.consumermedsafety.org/tools-andresources/medication-safety-tools-and-resources/consumer-medsafetylists/item/601-ten-tips-for-measuring-over-the-counter-liquid-medicationssafely. Accessed December 18, 2018. Assessment of the patient's knowledge about the components of self-medication, including the positive or negative consequences of the use of a given OTC drug, must be included. Assessment of the patient's (or caregiver's or family member's) level of knowledge and experience with OTC self-medication is critical to the patient's 369 safety, as is assessment of attitudes toward and beliefs about their use, especially a too-casual attitude or a lack of respect for and concern about the use of OTC drugs. This is especially true if a casual attitude is combined with a lack of knowledge. Obviously, this could result in overuse, overdosage, and potential complications. See Chapter 6 for more information on patient education. Laboratory tests are usually not ordered before the use of OTC drugs because they are self-administered and self-monitored. However, there are situations in which patients may be taking certain medications that react adversely with these drugs, and laboratory testing may be needed. Some patient groups are also at higher risk for adverse reactions to OTC drugs (as to most drugs in general), including pediatric and older adult patients; patients with single and/or multiple acute and chronic illnesses; those who are frail or in poor health, debilitated, or nutritionally deficient; and those with suppressed immune systems. OTC drugs must also be used with caution and may be contraindicated in patients with a history of renal, hepatic, cardiac, or vascular dysfunction. More assessment information for OTC drugs, herbals, and dietary supplements can be found in other chapters in this textbook when relevant (see Table 7.1). It is important to remember that consumer/patient safety and quality of care related to drug therapy of any kind begins with education. Thus the best way for patients to help themselves is for them to learn how to assess each situation, weigh all the factors, and find out all they can about the OTC drug they wish to take before taking it! Herbal Products and Dietary Supplements Many herbal products and dietary supplements are readily available in drug, health food, and grocery stores, as well as in home gardens, kitchens, and medicine cabinets. As noted earlier in the chapter, among the more commonly used herbals are aloe, black cohosh, chamomile, echinacea, feverfew, garlic, ginger, ginkgo biloba, ginseng, goldenseal, hawthorn, St. John's wort, saw palmetto, and valerian. Although patients generally self-administer these products and do not perform an assessment, in various settings you may be able to assess the patient through a head-to-toe physical 370 examination, medical and nursing history, and medication history. Share assessment data and factors and variables to consider with the patient for the patient's safety. This sharing of assessment information allows you to be sure that the patient is taking the herbal product in as safe a manner as possible. Many herbals and dietary supplements may lead to a variety of adverse effects. For example, some may cause dermatitis when used topically, whereas some taken systemically may be associated with kidney disorders such as nephritis. Therefore, for example, patients with existing skin problems or kidney dysfunction must seek medical advice before using certain herbals. It is also crucial to patient safety to consider any other contraindications, cautions, and potential drug-drug and drug-food interactions. See Table 7.3 for more information on drug interactions. Case Study Safety: What Went Wrong? Over-the-Counter Drugs and Herbal Products © David Gilder. J.V., a 28-year-old graduate student, is at the student health clinic for a physical examination that is required before he goes on a research trip out of the country. As he completes the paperwork, he asks the nurse, “The form is asking about my medications. I don't have any prescribed medicines, but I take several herbal products and over-the-counter (OTC) medicines. Do you need to know about these?” 371 1. How should the nurse answer J.V.? On the form, J.V. lists the following items: 1 baby aspirin each day to prevent blood clots Sleep-Well herbal product with valerian at night if needed Benadryl as needed for allergies, especially at night Stress-Away herbal product with ginseng as needed Generic ibuprofen, 3 or 4 tablets three times a day for muscle aches from working out Memory Boost herbal product with ginkgo every morning 2. J.V. tells you that he has been wondering why he bruises so easily, and shows you some bruises on his arms and his knees. Examine the products on J.V.'s list, and state whether there are any concerns with interactions or adverse effects. You may need to refer to descriptions of the individual herbal products (see the inside back cover for a complete listing of Safety: Herbal Therapies and Dietary Supplements boxes located throughout the textbook) or to the appropriate drug chapters for more information. What do you think has happened? 3. Upon further questioning, J.V. remembers that he has had problems with “acid stomach” for about a year and takes Prilosec-OTC for that as needed. What concerns, if any, are there about this? Human Need Statements Human need statements appropriate for the patient taking OTC drugs, herbals, and/or dietary supplements include the following (without related causes, because these are too numerous to include): 1. Altered gastrointestinal elimination 2. Altered knowledge 3. Altered need for sleep 4. Altered physical activity 5. Altered safety needs 372 6. Altered interchange of gases 7. Freedom from pain Planning: Outcome Identification 1. Patient states that the actions of the OTC drug, herbal, and/or dietary supplement have resulted in gastrointestinal upset. • Patient experiences relief of gastrointestinal upset when taking medications with food, as indicated, and with 6-8 ounces of water. 2. Patient states the therapeutic benefits of taking medications as instructed and without overuse. 3. Patient identifies measures to enhance healthy sleep habits such as warm bath/shower at bedtime, decreasing excessive stimulation (e.g., watching television), avoiding heavy meals late in the evening, and limiting caffeine in the late afternoon/early evening. 4. Patient describes ways to increase physical activity by the nonpharmacologic management of acute and chronic pain such as the use of hot or cold packs and physical therapy. 5. Patient implements safety measures, such as following instructions for drug therapy, use of comfort measures, increasing energy and strength with physical therapy, and maximizing nutritional intake as well as sleep, rest, and relaxation. 6. Patient states measures to increase deep breathing as well as avoidance of overuse of medications that may interfere with deep breaths. 7. Patient states measures to increase comfort/decrease pain through safe, effective dosing of OTC/herbal analgesics as well as non-drug measures (e.g., massage, relaxation techniques, use of heat or cold packs, biofeedback, acupuncture). Implementation With OTC drugs, herbals, and dietary supplements, patient education 373 is an important strategy to enhance patient safety. Patients need to receive as much information as possible about the safe use of these products and to be informed that, even though these are not prescription drugs, they are not completely safe and are not without toxicity. Include information about safe use, frequency of dosing and dose, specifics of how to take the medication (e.g., with food or at bedtime), as well as strategies to prevent adverse effects, drug interactions, and toxicity in the patient instructions. Another consideration is the dosage form, because a variety are available, such as liquids, tablets, enteric-coated tablets, transdermal patches, gum, and quick-dissolve tablets or strips. For transdermal patches (e.g., for smoking cessation), it is important to emphasize proper use and application. It is important to emphasize to the patient that OTC drugs, herbals, and/or dietary supplements are not regulated by the FDA unless there is sufficient data to support a recall of the product. Companies are not required to provide evidence of safety and/or effectiveness. As previously mentioned, many consumers believe there are no risks associated with OTC, herbal, and/or “natural” substances. See Box 7.1 for more information about the criteria for changing a drug from prescription to OTC status. The fact that a drug is an herbal or a dietary supplement does not mean that it can be safely administered to children, infants, pregnant or lactating women, or patients with certain health conditions that put them at risk. Evaluation Patients taking OTC drugs, herbals, and/or dietary supplements need to carefully monitor themselves for unusual or adverse reactions and therapeutic responses to the medication to prevent overuse and overdosing. The range of therapeutic responses will vary, depending on the specific drug and the indication for which it is used. Therapeutic responses also vary depending on the drug's action; a few examples are decreased pain; decreased stiffness and swelling in joints; decreased fever; increased activity or mobility, as in increased ease of carrying out ADLs; increased hair growth; increased ease in breathing; decrease in constipation, diarrhea, bowel irritability, or gastrointestinal reflux or hyperacidity; 374 resolution of allergic symptoms; decreased vaginal itching and discharge; increased healing; increased sleep; and decreased fatigue or improved energy. For more specific information about human need statements, planning with goals and outcome criteria, implementation, and evaluation related to various OTC drugs, herbals, and/or dietary supplements, see the appropriate chapters later in the book. Table 7.1 provides cross-references to these chapters. Patient-Centered Care: Patient Teaching • Provide verbal and written information about how to choose an appropriate OTC drug or herbal or dietary supplement as well as information about correct dosing, common adverse effects, and possible interactions with other medications. • Many patients believe that no risks exist if a medication is herbal and “natural” or if it is sold OTC, so provide adequate education about the drug or product as well as all the advantages and disadvantages of its use, because this is crucial to patient safety. • Provide instructions on how to read OTC drug, herbal, and dietary supplement labels and directions. Encourage the reading of ingredients if using more than one product, as the ingredient/chemical may occur in both products. For example, a multivitamin supplement may contain ginseng, and taking additional ginseng supplements may lead to toxicity. Another example is with products containing acetaminophen (Tylenol). If the patient is taking acetaminophen and then also takes a cold/flu product, there may also be acetaminophen in that product, and consequently the risk of adverse effects and toxicity increases. • Emphasize the importance of taking all OTC drugs, herbals, and dietary supplements with extreme caution, and being aware of all the possible interactions and/or concerns associated with the use of these products. • Patients need to consult with their health care 375 provider/prescriber prior to taking any herbal and/or OTC product. • Extreme caution with OTCs, herbals and dietary supplement use in the patient who is pregnant or lactating. • Instruct the patient that all health care providers (e.g., nurses, dentists, osteopathic and chiropractic physicians) need to be aware about the use of any OTC drugs, herbals, and dietary supplements (and, of course, any prescription drug use). • Encourage journaling of any improvement of symptoms noted with the use of a specific OTC drug, herbal, and/or dietary supplement. • Encourage the use of appropriate and authoritative resources for patient information, such as a registered pharmacist, literature provided from the drug company and pharmacist, and web-based information from reliable sites at an appropriate reading level for the patient (e.g., www.Webmd.com). • Instruct the patient that all medications, whether an OTC drug, herbal, and/or dietary supplement, must be kept out of the reach of children and pets. • Provide thorough instructions regarding the various dosage forms of OTC drugs, herbals, and dietary supplements. Provide specific instructions such as how to mix powders and how to properly use transdermal patches, inhalers, ointments, lotions, nose drops, ophthalmic drops, elixirs, suppositories, vaginal suppositories or creams, and all other dosage forms (see Chapter 9); also provide information about proper storage and cleansing of any equipment. Key Points • Consumers use herbal products therapeutically for the treatment of diseases and pathologic conditions, prophylactically for long-term prevention of disease, and proactively for the 376 maintenance of health and wellness. • The FDA has established the MedWatch program to track adverse events and/or problems related to drug therapy. The toll-free number for reporting adverse effects of prescription drugs, OTC drugs, herbals, and dietary supplements is 800-332-1088. Nurses may report adverse events anonymously and without consequence via telephone. Adverse event reporting is also available inside of medical reference applications such as Epocrates or Medscape. • Herbal products are not FDA-approved drugs, and therefore their labeling cannot be relied on to provide consumers and patients with adequate instructions for use or even information about warnings. • The fact that a drug is an herbal product, dietary supplement, or OTC medication is no guarantee that it can be safely administered to children, infants, pregnant or lactating women, or patients with certain health conditions that may put them at risk. Critical Thinking Exercises 1. The nurse is discussing over-the-counter (OTC) drugs and herbal products with neighbors. One neighbor comments, “Oh, the over-the-counter drugs and herbals are safe. As long as you use the recommended amounts, there won't be any bad side effects.” What is the nurse's best response? 377 2. A patient tells the clinic nurse that he has been taking a “blood thinner” for several months and wants to ask about taking garlic capsules to reduce his blood pressure. He says his sister uses it and it “works wonders.” He also says, “I think it would be safe because I can buy it at the drug store. They wouldn't sell harmful drugs.” What is the nurse's best response? (You may need to look up the drug warfarin and the herbal product elsewhere in the textbook.) Review Questions 1. The nurse is reviewing dietary supplements and US Food and Drug Administration (FDA) requirements. Which of these actions are required by the FDA for manufacturers of dietary supplements? a. Follow FDA standards for quality control. b. Prove efficacy and safety of dietary supplements. c. Identify the active ingredients on the label. d. Obtain FDA approval before the products are marketed. 2. When educating patients about the safe use of herbal products, the nurse remembers to include which concept? a. Herbal and over-the-counter (OTC) products are approved by the FDA and under strict regulation. b. Herbal products are tested for safety by the FDA and the US Pharmacopeia. c. No adverse effects are associated with these products because they are natural and may be purchased without a prescription. d. Take the products with caution because labels may 378 not contain reliable information. 3. When taking a patient's drug history, the nurse asks about use of OTC drugs. The patient responds by saying, “Oh, I frequently take aspirin for my headaches, but I didn't mention it because aspirin is nonprescription.” What is the nurse's best response? a. “That's true; over-the-counter drugs are generally not harmful.” b. “Aspirin is one of the safest drugs out there.” c. “Although aspirin is over the counter, it's still important to know why you take it, how much you take, and how often.” d. “We need you to be honest about the drugs you are taking. Are there any others that you haven't told us about?” 4. The nurse is reviewing interactions between drugs and herbal products. Which of these herbal products may interact with anticoagulants, resulting in altered bleeding? (Select all that apply.) a. chamomile b. ginkgo c. echinacea d. kava e. garlic 5. A patient tells the nurse that he has been using an herbal supplement that contains kava for several years to help him to relax in the evening. However, the nurse notes that he has a yellow tinge to his skin and sclera, and is concerned about liver toxicity. The nurse advises the patient to stop taking the kava and to see his health care provider for an examination. What else, if anything, 379 should the nurse do at this time? a. Report this incident to MedWatch. b. Notify the state's pharmaceutical board. c. Contact the supplement manufacturer. d. No other action is needed. 6. The nurse is reviewing the drug history of a patient, and during the interview the patient asks, “Why are some drugs OTC and others are not?” The nurse keeps in mind that criteria for OTC status include: (Select all that apply.) a. The condition must be diagnosed by a health care provider. b. The benefits of correct usage of the drug outweigh the risks. c. The drug has limited interaction with other drugs. d. The drug is easy to use. e. The drug company sells OTC drugs at lower prices. 7. A patient comes to the clinic complaining of elbow pain after an injury. He states that he has been taking two pain pills, eight times a day, for the past few days. The medication bottle contains acetaminophen, 325-mg tablets. Calculate how much medication he has been taking per day. Is this a safe dose of this medication? 8. The nurse is reviewing definitions for a pharmacology review class. Which of these products would be categorized as “legend drugs?” (Select all that apply.) a. acetaminophen (Tylenol) b. warfarin (Coumadin) c. gingko biloba d. morphine sulfate 380 e. diphenhydramine (Benadryl) References Institute for Safe Medication Practices. A call to action: protecting U.S. citizens from inappropriate medication use. [Available at] www.ismp.org/pressroom/viewpoints/CommunityPharmacy Limdi NA, et al. Influence of CYP2C9 and VKORC1 1173C/T genotype on the risk of hemorrhagic complications in African-American and EuropeanAmerican patients on warfarin. Clinical Pharmacology & Therapeutics. 2008;83:312–321. Many patients do not disclose complementary/alternative treatments. [Available at] http://genelex.com/blog/many-patients-do-notdisclose-complementaryalternative-treatments. National Center for Complementary and Alternative Medicine website. [Available at] http://nccam.nih.gov. Petro-Yura H, Walsh MB. Human needs 2 and the nursing process. Catholic University of America Press: Washington DC, Catholic; 1983. Qato DM, Wilder J, Schumm LP, et al. Changes in prescription and over-the-Counter medication and dietary supplement use among older adults in the United States, 2005 vs 2011. JAMA Internal Medicine. 2016;176:473. Shehab N, Schaefer MK, Kegler SR, et al. Adverse events from cough and cold medications after a market withdrawal of products labeled for infants. Pediatrics. 2010;126:1100–1107. Tachjian A, Maria V, Jahangir A. Use of herbal products and potential interactions in patients with 381 cardiovascular diseases. Journal of the American College of Cardiology. 2010;55:515–525. US Food and Drug Administration. Acetaminophen and liver injury: Q & A for consumers. [Available at] www.fda.gov/forconsumers/consumerupdates/ucm168830.h US Food and Drug Administration. Dietary supplements. [Available at] www.fda.gov/food/dietarysupplements/default.htm Yasuda SU, Zhang L, Huang SM. The role of ethnicity in variability in response to drugs: focus on clinical pharmacology studies. Clinical Pharmacology and Therapeutics. 2008;84(3):417–423. 382 8 Gene Therapy and Pharmacogenomics OBJECTIVES When you reach the end of this chapter, you will be able to do the following: 1. Understand the basic terms related to genetics and drug therapy. 2. Briefly discuss the major concepts of genetics as an evolving segment of health care, such as principles of genetic inheritance; deoxyribonucleic acid (DNA), ribonucleic acid (RNA), and their functioning; the relationship of DNA to protein synthesis; and the importance of amino acids. 3. Describe the basis of the Human Genome Project (HGP) and its impact on the role of genetics in health care. 4. Discuss the different gene therapies currently available. 5. Differentiate between direct and indirect forms of gene therapy. 6. Identify the regulatory and ethical issues related to gene therapy as related to nursing and health care professionals. 7. Briefly discuss pharmacogenomics and pharmacogenetics. 8. Discuss the evolving role of professional nurses as related to gene therapy. 383 KEY TERMS Acquired disease Any disease triggered by external factors and not directly caused by a person's genes (e.g., an infectious disease, noncongenital cardiovascular diseases). Alleles The two or more alternative forms of a gene. Chromosomes Structures in the nuclei of cells that contain threads of DNA, which transmit genetic information, and are associated with RNA molecules and synthesis of protein molecules. Gene The biologic unit of heredity; a segment of a DNA molecule that contains all of the molecular information required for the synthesis of a biologic product such as an RNA molecule or an amino acid chain (protein molecule). Gene therapy New therapeutic technologies that directly target human genes in the treatment or prevention of illness. Genetic disease Any disorder caused directly by a genetic mechanism. Genetic material DNA or RNA molecules or portions thereof. Genetic polymorphisms (PMs) Variants that occur in the chromosomes of 1% or more of the general population. Genetic predisposition The presence of certain factors in a person's genetic makeup, or genome that increase the individual's likelihood of developing one or more diseases. Genetics The study of the structure, function, and inheritance of genes. Genome The complete set of genetic material of any organism. Genomics The study of the structure and function of the genome, and the way genes and their products work in both health and disease. Genotype The particular alleles present at a given site on the 384 chromosomes that determine a specific genetic trait for that organism (compare phenotype). Heredity The characteristics and qualities that are genetically passed from one generation to the next through reproduction. Human genome project (HGP) A scientific project of the US Department of Energy and National Institutes of Health (NIH) to describe in detail the entire genome of a human being. Inherited disease Genetic disease that results from defective alleles passed from parents to offspring. Nucleic acids Molecules of DNA and RNA in the nucleus of every cell. DNA makes up the chromosomes and encodes the genes. Personalized medicine The use of molecular and genetic characterizations of both the disease process and the patient for the customization of drug therapy. Pharmacogenetics A general term for the study of the genetic basis for variations in the body's response to drugs, with a focus on variations related to a single gene. Pharmacogenomics A branch of pharmacogenetics (see earlier) that involves the survey of the entire genome to detect multigenic (multiple-gene) determinants of drug response. Phenotype The expression in the body of a genetic trait that results from a person's particular genotype (see earlier) for that trait. Recombinant DNA (rDNA) DNA molecules that have been artificially synthesized or modified in a laboratory setting. Overview Genetic processes are a highly complex part of physiology and are far from completely understood. Genetic research is one of the most active branches of science today. Expected outcomes of this research include a deeper knowledge of the genetic influences on disease, along with the development of gene-based therapies. In 1996, the National Coalition for Health Professional Education in 385 Genetics (NCHPEG) was founded as a joint project of the American Medical Association, the American Nurses Association, and the National Human Genome Research Institute (www.nchpeg.org). The purpose of NCHPEG is to promote the education of health professionals and the public regarding advances in applied genetics. Since the 1960s, published literature has described the role of nursing in genetics and genetic research. The Genetics Nursing Network was formed in 1984 and later became the International Society of Nurses in Genetics (ISONG). In 1997, the American Nurses Association designated genetics nursing as an official nursing specialty. In 2001, ISONG approved formation of the Genetic Nursing Credentialing Commission (GNCC). The growing understanding of genetics is creating demand for clinicians in all fields who can educate patients and provide clinical care that tailors health care services to each patient's inherent genetic makeup. This reality also calls for increasing the level of genetics education in nursing school curricula as well as continuing nursing education. Basic Principles of Genetic Inheritance Nucleic acids are biochemical compounds consisting of two types of molecules: deoxyribonucleic acid (DNA) and ribonucleic acid (RNA). DNA molecules make up the genetic material that is passed between all types of organisms during reproduction. A chromosome is a long strand of DNA that is contained in the nuclei of cells. DNA molecules, in turn, act as the template for the formation of RNA molecules, from which proteins are made. Humans normally have 23 pairs of chromosomes. Alleles are the alternative forms of a gene that can vary with regard to a specific genetic trait. Genetic traits can be desirable (e.g., lack of allergies) or undesirable (e.g., predisposition toward a specific disease). An allele may be dominant or recessive for a given genetic trait. A person's genotype for a given trait determines whether or not a person manifests that trait, or the person's phenotype. Genetic traits that are passed on differently to male and female offspring are said 386 to be sex-linked traits because they are carried on either the X or Y chromosome. For example, hemophilia genes are carried by females but manifest as a bleeding disorder only in males. Hemophilia is an example of an inherited disease—that is, a disease caused by passage of a genetic defect from parents to offspring. A more general term is genetic disease, which is any disease caused by a genetic mechanism. Not all genetic diseases are inherited. Chromosomal abnormalities (aberrations) can also occur spontaneously during embryonic development. In contrast, an acquired disease is any disease that develops in response to external factors and is not directly related to a person's genetic makeup. Genetics can play an indirect role in acquired disease, however. For example, atherosclerotic heart disease is often acquired in middle or later life. Many people have certain genes in their cells that increase the likelihood of this condition. This is known as a genetic predisposition. In some cases, a person may be able to offset his or her genetic predisposition by lifestyle choices, such as consuming a healthy diet and exercising to avoid developing heart disease. Current literature differentiates “old genetics,” which focused on single-gene inherited diseases such as hemophilia, from the “new genetics.” The new genetic perspective recognizes that common diseases, including Alzheimer's disease, cancer, and heart disease, are the product of complex relationships between genetic and environmental factors. Environmental factors, such as diet or toxic exposures, can initiate or worsen disease processes. Research into disease treatment is beginning to look at genetically tailored therapy. Discovery, Structure, and Function of DNA Genetics is the study of the structure, function, and inheritance of genes. Heredity refers to the qualities that are genetically transferred from one generation to the next during reproduction. A major turning point in the understanding of genetics came in 1953, when Drs. James Watson and Francis Crick first reported the 387 chemical structures of human genetic material and named the primary biochemical compound DNA. They later received a Nobel Prize for their discovery. It is now recognized that DNA is the primary molecule in the body that serves to transfer genes from parents to offspring. DNA molecules contain four different organic bases, which are linked to a type of sugar molecule known as deoxyribose. In turn, these sugar molecules are linked to a “backbone” chain of phosphate molecules, which results in the classic double-helix structure of two side-byside spiral macromolecular chains. An important related biomolecule is RNA. RNA has a chemical structure similar to that of DNA. RNA most commonly occurs as a single-stranded molecule. Certain new drug therapies involve synthetic analogues of both nucleosides and nucleotides (see Chapters 40, 45, 46, and 47). A related field is targeted drug therapy. Targeted drug therapy focuses on modifying the function of immune system cells (T cells and B cells) and biochemical mediators of immune response (cytokines). Current examples of targeted drug therapy are presented in Chapters 45, 46, and 48. An organism's entire DNA structure is its genome, and refers to all the genes in an organism taken together. Genomics is the relatively new science of determining the location (mapping), structure (DNA base sequencing), identification (genotyping), and expression (phenotyping) of individual genes along the entire genome, and determining their function in both health and disease processes. Protein Synthesis Protein molecules drive the functioning of all biochemical reactions. Protein synthesis is the primary function of DNA in human cells. Mutations, undesired changes in DNA sequence, can affect the shape of protein molecules and impair or destroy their functioning. In the cell nuclei, the double strands of DNA uncoil and separate, and a strand of mRNA forms on each separate DNA strand. This process is called transcription of the DNA. These mRNA molecules then detach from their corresponding DNA strands, leave the cell nucleus, and enter the cytoplasm, where they are then “read,” or 388 translated, by the ribosomes. Ribosomes are composed of a second type of RNA known as ribosomal RNA (rRNA). This translation process involves molecules of a third type of RNA, transfer RNA (tRNA). This whole process results in the creation of chains of multiple amino acids (polypeptide chains), which are known as protein molecules. Proteins include hormones, enzymes, immunoglobulins, and numerous other biochemical molecules that regulate processes throughout the body. They are involved in both healthy physiologic processes and the pathophysiologic processes of many diseases. Manipulation of genetic material, as in gene therapy, can theoretically modify the synthesis of these proteins and therefore aid in the treatment of disease. Genetic testing and counseling are important for patients. Genetic counseling allows patients who are at risk for an inherited disorder to be advised of the consequences and nature of the disorder, the probability of developing or transmitting it, and the options open to them. One of the most common genetic testing is for the BRCA gene for breast cancer. Other common examples of genetic testing are prenatal testing to determine if a future child may have cystic fibrosis or Down syndrome. Human Genome Project In 1990, an unprecedented genetic research project began in the United States, the Human Genome Project (HGP), and was coordinated by the US Department of Energy and the National Institutes of Health (NIH). The project was completed in 2003, 2 years ahead of schedule. The goals of this project were to identify the estimated 30,000 genes and 3 billion base pairs in the DNA of an entire human genome. Additional goals included developing new tools for genetic data analysis and storage, transferring newly developed technologies to the private sector, and addressing the inherent ethical, legal, and social issues involved in genetic research and clinical practice. Gene Therapy Background 389 Gene therapy is an experimental technique that uses genes to treat or prevent disease. It allows doctors to treat a disorder by inserting a gene into a patient's cells instead of using drugs or surgery. Researchers are testing several approaches to gene therapy, including: • Replacing a mutated gene with a healthy copy of the gene • Introducing a new gene into the body to help fight a disease • Inactivating a mutated gene that is functioning improperly Hundreds of gene therapy clinical trials have been approved by the US Food and Drug Administration (FDA), and the first gene therapy was approved in 2017. Voretigene neparvove-rzl (Luxturna) is the first gene therapy approved for a genetic disease: confirmed biallelic RPE65 mutation-associated retinal dystrophy. The number of approved gene therapies is expected to rapidly multiply. The cost of gene therapy is expected to be 20 to 30 times the annual income of the average American. The goal of gene therapy is to transfer exogenous genes that will either provide a temporary substitute for, or initiate permanent changes in, the patient's own genetic functioning to treat a given disease. Originally projected to provide treatment primarily for inherited genetic diseases, gene therapy techniques are now being researched for treatment of acquired illnesses such as cancer, cardiovascular diseases, diabetes, infectious diseases, and substance abuse. In the future, in utero gene therapy may be used to prevent the development of serious diseases as part of prenatal care for the unborn infant. During gene therapy, segments of DNA are injected into the patient's body in a process called gene transfer. These artificially produced DNA splices are also known as recombinant DNA (rDNA). There are limitations to gene therapy, and the determination of an ideal gene transfer method remains a major challenge for gene therapy researchers. Viruses used for gene transfer can induce viral 390 disease and can be immunogenic in the human host. The proteins produced by artificial methods can be immunogenic. Fig. 8.1 provides a clinical example of the potential use of gene therapy. FIG. 8.1 Gene therapy for adenosine deaminase (ADA) deficiency attempts to correct this immunodeficiency state. The viral vector containing the therapeutic gene is inserted into the patient's lymphocytes. These cells can then make the ADA enzyme. (From Lewis, S. L., Bucher, L., Heitkemper, M. M., Harding, M. [2017]. Medical-surgical nursing: assessment and management of clinical problems [10th ed]. St. Louis: Elsevier.) Current Application One indirect form of gene therapy is well established and is called rDNA technology. It involves the use of rDNA vectors in the laboratory to make recombinant forms of drugs, especially biologic drugs such as hormones, vaccines, antitoxins, and monoclonal antibodies. The most common example is the use of the Escherichia coli bacterial genome to manufacture a recombinant form of human insulin. When the human insulin gene is inserted into the genome of the bacterial cells, the resulting culture artificially generates 391 human insulin on a large scale. Although this insulin must be isolated and purified from its bacterial culture source, the majority of the world's medical insulin supply has been produced by this method for well over a decade. Regulatory and Ethical Issues Regarding Gene Therapy Gene therapy research is inherently complex and can also carry great risks for its recipients. Thus the issue of patient safety becomes significant. Research subjects who receive gene therapy often have a life-threatening illness, such as cancer, which may justify the risks involved. The FDA must review and approve all human clinical gene therapy trials, as it does for any type of drug therapy. Any institution that conducts any type of research involving human subjects must have an institutional review board, whose purpose is to protect research subjects from unnecessary risks. Also required for institutions engaging in gene therapy research is an institutional biosafety committee. The role of this committee is to ensure compliance with the NIH Guidelines for Research Involving rDNA Molecules. A major ethical issue related to gene therapy is that of eugenics. Eugenics is the intentional selection before birth of genotypes that are considered more desirable than others. For similar reasons, the prospect of being able to manipulate genes in human germ cells (sperm and eggs) is also a potential ethical hazard of gene therapy. Pharmacogenetics and Pharmacogenomics Pharmacogenetics is a general term for the study of genetic variations in drug response and focuses on single-gene variations. A related science that pertains more directly to the HGP is pharmacogenomics. Pharmacogenomics is the combination of two scientific disciplines: pharmacology and genomics. Pharmacogenomics involves how genetics (genome) affect the 392 body's response to drugs. Pharmacogenomics offer physicians the opportunity to individualize drug therapy based on a patient's genetic makeup. The ultimate goal is to predict patient drug response and proactively tailor drug selection and dosages for optimal treatment outcomes. Certain drugs have pharmacogenomic guidelines; a selected representation is listed in Box 8.1. Warfarin is an anticoagulant drug that is used to prevent blood clots (see Chapter 26). Research has shown that people with certain genetic variations (CYP2C9*2 or CYP2C9*3 alleles) are at increased risk for bleeding and require lower doses than those without the variation. In addition, variations in the gene that encodes VKORC1 may make a patient more or less sensitive to warfarin. This genetic variation occurs most frequently in the Asian population. Several new drugs have been approved recently that target certain genes, including Ivacaftor (Kalydeco) for the treatment of cystic fibrosis and dabrafenib (Tafinlar) for the treatment of melanoma. Box 8.1 Selected Drugs With Pharmacogenomic Guidelines Abcavir Acetaminophen with codeine Allopurinol Amitriptyline Carbamazepine Citalopram Escitalopram Phenytoin Sertraline Simvastatin Warfarin Individual differences in alleles that occur in at least 1% of a population are known as genetic polymorphisms (PMs). The word polymorphism literally means “many forms.” Polymorphisms are 393 considered to be too frequent to result from random genetic mutations. Polymorphisms that alter the amount or actions of drugmetabolizing enzymes can alter the reactions to medications. Known examples include those PMs that affect the metabolism of certain antimalarial drugs, the antituberculosis drug isoniazid, and the variety of drugs that are metabolized by the subtypes of cytochrome (CYP) enzymes. Differences in CYP enzymes (see Chapter 2) are the best-studied PM effects thus far. Depending on their existing genes for these enzymes, patients can be genetically classified as “poor” or “rapid” metabolizers of CYP-metabolized drugs such as warfarin, phenytoin, codeine, and quinidine. With warfarin and phenytoin, a rapid metabolizer may need a higher dose of medication for the same effect, whereas a lower dose may be best for a poor metabolizer. With codeine, a poor metabolizer may actually need a higher dose to get the same analgesic effect that occurs when codeine is metabolized to morphine. In contrast, a rapid metabolizer may convert codeine to morphine too quickly, resulting in oversedation, and a lower dose may be sufficient. Because CYP enzymes are known to vary among racial and ethnic groups, the principle of “cultural safety” becomes one of the imperatives for routine gene-based drug dosing. Studying both the genome of the patient and the genetic features of the pathology (e.g., tumor cells, infectious organisms) before treatment could allow for customized drug selection and dosing. Such analysis could permit the avoidance of drugs not likely to be effective as well as optimization of drug dosages to minimize the risk for adverse drug effects. These applications of pharmacogenomics are examples of personalized medicine. Table 8.1 lists several examples of current clinical applications of pharmacogenomics. TABLE 8.1 Clinical Applications of Pharmacogenomics Genetic Technique Genotyping for the presence of the CYP2D6 isoenzyme and for CYP2D6 alleles determining whether patients are poor, intermediate, extensive, or Application Psychiatry and general medicine: Helps guide the prescribing of selected medications such as anticoagulants, immunosuppressants, antidepressants, 394 ultra-rapid metabolizers related to these enzymes (under study) antipsychotics, mood stabilizers, anticonvulsants, beta blockers, and antidysrhythmics Genotyping for the presence of the p- Cardiology, infectious diseases, oncology, and glycoprotein drug transport protein other practice areas: Assists in drug selection (under study) and dosing for drugs such as digoxin, antiretrovirals, and antineoplastics Genotyping for variations in betaPulmonology: Determines which asthma adrenergic receptors (under study) patients are more or less responsive to beta-agonist therapy (e.g., albuterol) and which patients might benefit from other types of drug therapy Genotyping for the presence of the Oncology: Identifies a subset of breast HER2/neu protooncogene cancer patients whose tumors express this gene, which indicates their suitability for treatment with the cancer drug trastuzumab (Herceptin) Viral genotyping of hepatitis C viruses Infectious diseases: Can determine whether a (under study) particular infection warrants 26 versus 48 weeks of drug therapy (thereby reducing both costs and adverse drug effects) Genotyping for the presence of factor Women's health: Identifies women with a 7– V gene mutation 100 times greater risk of thrombosis with oral contraceptive use compared to women without the mutation Genotyping for the presence of Cardiology: Allows refined sodium channels associated with antihypertensive drug selection renin-angiotensin receptors and adrenal gland receptors Race-based drug selection Cardiology: Indicates use of the drug isosorbide dinitrate/hydralazine (BiDil) for treatment of hypertension in African American patients due ultimately to genotypic variations in this patient population CYP2D6, Cytochrome P-450 enzyme subtype 2D6; HER2/neu, human epidermal growth factor receptor 2. Application of the Nursing Process as Related to Genetic Principles As noted previously, the recognition that genetic factors contribute, at some level, to most diseases continues to grow. Thus, genetic influences on health, including the interaction of genetic and 395 environmental (nongenetic) factors, will routinely affect nursing care delivery. In general, the influence of genetic research is found in clinical practice settings every day. Nurses in general practice settings will not be expected to perform in-depth genetic testing or counseling. Nurses—or other health care providers—with specialty certification in the field of genetics may be involved in the process of genetic counseling and testing. However, all nurses will need to have a working knowledge of relevant genetic principles and their application to nursing care including drug therapy. In this era of the genetic paradigm, nurses are fully aware of the fact that nearly all diseases have a genetic component. Conditions such as myocardial infarction, cancer, mental illness, diabetes, and Alzheimer's disease are now viewed in a different light because of the known complex interactions between a number of factors, including the influence of one or more genes and a variety of environmental exposures and genetic mutations for all ages of patients. For more information about the need for more genetic content within undergraduate nursing education curriculum, see the Evidence-Based Practice box. There are several other applicable skills regarding genetics as related to the nursing process. It is during the assessment phase of patient care that the nurse may uncover factors that may point to a risk for genetic disorders. Also, during the initial assessment, the nurse needs to obtain the patient's personal and family history. The family history is most effective if it covers at least three generations and includes the current and past health status of each family member. Assessment of factors possibly indicating an increased risk for genetic disorders is also important. A few examples of such factors include a higher incidence of a particular disease or disorder in the patient's family than in the general population; diagnosis of a disease in family members at an unusually young age; or diagnosis of a family member with an unusual form of cancer or with more than one type of cancer. It is also important to inquire about any unusual reactions to a drug—on the part of the patient, family members, significant others, and/or caregivers. An unusual or other than expected reaction to a drug in family members may point to a difference in the patient's ability to metabolize certain drugs. As indicated earlier 396 in the chapter (as well as in Chapter 2), genetic factors may alter a patient's metabolism of a particular drug, resulting in either increased or decreased drug action. Each and every time a medication is administered, the patient's response to that drug must be assessed. Any unusual medication responses in a patient may point to a need for further investigation. Once a genetic variation is known, drug therapy may be adjusted accordingly. As DNA chip technology becomes more affordable and accessible, it will be possible for patients to know in advance their relative risks for different diseases in later life. Genotype testing to identify a patient's drug-metabolizing enzymes will help prescribers better predict a patient's response to drug therapy. Teaching about genetic testing and counseling may be another responsibility expected of the nurse. Patients will have questions and concerns about genetic testing and other issues. Nurses in general practice are not experts in genetic issues. However, the nurse may help with suggestions about genetic counseling, if appropriate. If genetic testing is ordered, the nurse may be a part of the testing process and will need to ensure that the informed decision-making and consent procedure has been carried out correctly. Maintaining privacy and confidentiality is of utmost importance during genetic testing and counseling. The patient is the one who decides whether to include or exclude any family members from the discussion and from knowledge of the results of genetic testing. The patient needs to be reminded that he or she is not required to undergo the genetic test and that the patient has the right to disclose or withhold test results from anyone. Nurses must protect against improper disclosure of information to other family members, friends of the family, other health care providers, and insurance providers. Nurses share the responsibility with other health care providers to protect patients and their families against the misuse of a patient's genetic information. Other responsibilities of the professional nurse may include development of clinical and social policy such as genetic nondiscrimination and prenatal testing policies, testing of genetic products for reliability, and tasks in genetic informatics to meet the challenge of sifting through a continually expanding body of knowledge. 397 Evidence-Based Practice Integrating Genomics Into Undergraduate Nursing Education Review Scientists continue to make discoveries that contribute to the knowledge base and understanding of how human health and disease are impacted by genomics. No matter the setting of health care delivery, genomics will continue to change the approach to many aspects of medicine. The nursing profession, in order to keep up with these changes, needs to emphasize the importance and significance of genomics in their approaches to education and practice. Genomics is integral in the diagnosis, treatment, and prevention of disease. The purpose of this review of research and literature was to show the significance for the need to prepare the next generation of nurses. In addition, faculty are now confronted with the challenge of integrating and incorporating genomics into nursing curriculum. This article and review presents a discussion on meeting of this challenge. Methodology The organizing construct of this review includes steps to initiate curricular changes on how to include genomics into nursing curriculum. The question is whether it is more effective to create a genomic curriculum thread versus a stand-alone course (on genomics). The evidence presented is based on information gathered from a review of the literature as well as curriculum changes by the authors. Findings Some of the models for integrating genomics into undergraduate nursing curriculum include the following: integration with facultyinitiated change, creating a curriculum thread focused on genomics, developing a stand-alone required or elective course, clinical practicums and/or simulation, and incorporating printed materials (bulletin boards) and/or technology (clickers, Web 398 Quests, blogs). In recognition of the advances in genomics, there must be an increasing emphasis on the integration of this content into professional nursing practice, and more importantly, nursing education. Information must be included within didactic courses and then reinforced in the context of clinical settings while also using current technological advances/resources. Application to Nursing Practice There is an undeniable need to prepare our next generation of nurse clinicians in the world of genomics. This need begins with the change in undergraduate nursing curriculum with faculty participation from the beginning of all planning and change. With application of the nursing process to nursing research and nursing education, assessment of faculty knowledge must be followed by implementation of a plan for integrating genetics and genomics into nursing courses and clinical experiences. Further research of a multifaceted approach with use of didactic courses, clinical practicum with various delivery elements, and current platforms is needed for delineating the most effective ways of presenting this crucial content in undergraduate nursing programs. Data from Daack-Hirsch, S., Dieter, C., & Quinn Griffin, M. T. (2011). Integrating genomics into undergraduate nursing education. Journal of Nursing Scholarship, 43(3), 223–230. Case Study Patient-Centered Care: Genetic Counseling © Felix Mizioznikov. S.W. a 38-year old female, has several family members who have 399 been diagnosed with breast cancer. S.W. decides to undergo genetic testing for the BRCA gene. Today, she found out that the testing indicates a strong chance of developing breast cancer. Her physician recommends that she undergo a bilateral mastectomy soon to avoid the possibility of developing breast cancer and suggests that she share this information with her sisters and her daughter, who is 18 years old. After the physician leaves, the patient tells the nurse, “I don't know what to do. I haven't talked to one of my sisters for years and I just know she won't believe me. I also don't want to worry my daughter. She is so young, and I'm sure she's too young to get cancer.” 1. Should the nurse tell the patient's sister and daughter? Explain your answer. 2. What is the best way for the nurse to handle this situation? Summary Increasing scientific understanding of genetic processes continues to revolutionize modern health care in many ways. The artificial manipulation and transfer of genetic material is the focus of hundreds of current human clinical gene therapy trials. The spectrum of diseases that may eventually be treatable by gene therapy includes inherited diseases that are present from birth, disabilities such as paralysis from spinal cord injuries, and lifethreatening illnesses such as cancer. The science of pharmacogenomics has already identified some of the genetic nuances in how different individuals’ bodies metabolize drugs to their benefit or harm. Continued study in this area is expected to result in proactive customization of drug therapy to promote therapeutic benefits while minimizing or eliminating toxic effects. Genetic procedures and therapeutic techniques will continue to play an increasingly important facet of nursing practice as well as of health care delivery, in general. Key Points 400 • Genetic processes are a highly complex facet of human physiology, and genetics is becoming an integral part of health care that holds much promise in the form of new treatments for alterations in health. • The HGP, spearheaded by the US Department of Energy and the NIH, describes in detail the entire genome of a human individual. • Basic genetic inheritance is carried by 23 pairs of chromosomes in each of the somatic cells; one pair of chromosomes in each cell is the sex chromosomes, identified as XX for females and XY for males. • Applicable skills for general nurses include taking thorough patient, family, and drug histories, recognizing situations that may warrant further investigation through genetic testing, identifying resources for patients, maintaining confidentiality and privacy, and ensuring that informed consent is obtained for genetic testing and counseling. Critical Thinking Exercises 1. You are working on a medical-surgical unit and performing an assessment on a newly admitted patient. During the assessment, your patient states, “My doctor told me that I need to have genetic testing. I just don't understand. If they change my genes, then it will change the way I look!” What is the priority as you, the nurse, answer the patient's concerns? 2. During the nurse's assessment of a newly admitted 401 patient, the patient tells the nurse, “I'm allergic to codeine. Whenever I take it, it just knocks me out!” The patient tells the nurse that codeine does the same thing to all of her siblings. She insists that she's been allergic to codeine all of her life. Does the patient have an actual allergy to codeine? What else could be happening? Review Questions 1. Which of these are examples of a product formed by an indirect form of gene therapy? (Select all that apply.) a. Monoclonal antibodies b. Vaccines c. Hormones d. Antitoxins e. Stem cells 2. The nurse is explaining the general goal of gene therapy to a patient. With gene therapy, the general goal is to transfer exogenous genes to a patient for which result? a. To change the patient's own genetic functioning to treat a given disease b. To improve drug metabolism c. To prevent genetic disorders in the patient's future children d. To stimulate the growth of stem cells 3. The nurse is reviewing genetic concepts. Which is considered the biologic unit of heredity? a. Gene b. Allele c. Chromosome 402 d. Nucleic acid 4. The presence of certain factors in a person's genetic makeup that increase the likelihood of eventually developing one or more diseases is known as which of these? a. Genetic mutation b. Genetic polymorphism c. Genetic predisposition d. Genotype 5. The nurse is reviewing gene therapy. Which is the primary molecule in the body that serves to transfer genes from parents to offspring? a. RNA b. DNA c. Allele d. Chromosome 6. General responsibilities of the nurse regarding genetics may include which of these activities? (Select all that apply.) a. Assessing the patient's personal and family history b. Referring the patient to a genetic counselor or other genetics specialist c. Communicating the results of genetic tests to the patient and patient's family d. Maintaining privacy and confidentiality during the testing process e. Answering questions about genetic test results 7. The nurse is assessing a patient for a possible increased risk for genetic disorders. Which of these, if present, may 403 indicate an increased risk for a genetic disorder? (Select all that apply.) a. Having a brother who died of a myocardial infarction at age 29 b. Having a family member who has been diagnosed with more than one type of cancer c. Having an uncle who was diagnosed with prostate cancer at age 73 d. A history of allergy to shellfish and iodine e. Having a maternal grandmother, two maternal aunts, and a sister who were diagnosed with colon cancer 8. Liquid potassium chloride is ordered as follows: Give 16 mEq per percutaneous endoscopic gastrostomy (PEG) tube twice a day. The dose on hand contains 20 mEq/15 mL. How much will the nurse give per dose? References Bachtiar M, Lee CG. Genetics of population differences in drug response. Current Genetic Medicine Reports. 2013;1:162–170. Beurner JH. Without therapeutic drug monitoring, there is no personalized cancer care. Clinical Pharmacology & Therapeutics. 2013;93(3):228–230. Calzone KA. A blueprint for genomic nursing science. Journal of Nursing Scholarship. 2013;45(1):96–104. Gene testing, gene therapy, pharmacogenomics. [Human Genome Project Information website; Available at] www.ornl.gov/sci/techresources/Human_Genome/home.shtm Thummel KE, Lin YS. Sources of interindividual variability. Methods in Molecular Biology. 404 2014;1113:363. Wang B, Canestaro WJ, Choudhry NK. Clinical evidence supporting pharmacogenomic biomarker testing provided in US Food and Drug Administration drug labels. JAMA Internal Medicine. 1938;174:2014. 405 9 Photo Atlas of Drug Administration Preparing for Drug Administration NOTE: This photo atlas is designed to illustrate general aspects of drug administration. For detailed instructions, please refer to a nursing fundamentals or nursing skills book. When giving medications, remember safety measures and correct administration techniques to avoid errors and to ensure optimal drug actions. Keep in mind the “Nine Rights”—right drug, right dose, right time, right route, right patient (using two identifiers), right documentation, right reason for the medication, right response to the medication, and the patient's right to refuse. Refer to Chapter 1 for additional rights regarding drug administration. Other things to keep in mind when preparing to give medications are as follows: • Remember to perform hand hygiene before preparing or giving medications (Box 9.1). Box 9.1 Standard Precautions Always adhere to standard precautions, including the following: 406 • Wear clean gloves when exposed to or when there is potential exposure to blood, body fluids, secretions, excretions, and any items that may contain these substances. Always wash hands immediately when there is direct contact with these substances or any item contaminated with blood, body fluids, secretions, or excretions. Also wear gloves for touching mucous membranes and nonintact skin, and when giving injections. Gloves may be necessary during medication preparation. Be sure to assess the patient for latex allergy and use nonlatex gloves if indicated. • Perform hand hygiene after removing gloves and between patient contacts. According to the Centers for Disease Control and Prevention, the preferred method of hand decontamination is with an alcohol-based hand rub, but washing with an antimicrobial soap and water is an alternative to the alcohol rub. Use soap and water to wash hands when hands are visibly dirty or after caring for a patient infected with Clostridium difficile. • Perform hand hygiene: • Before direct contact with patients • After contact with blood, body fluids, excretions, mucous membranes, wound dressings, or nonintact skin • After contact with a patient's skin (i.e., when taking a pulse or positioning a patient) • After removing gloves • Wear a mask, eye protective gear, and face shield during any procedure or patient care activity with the potential for splashing or spraying of blood, body fluids, secretions, or excretions. Use of a gown may also be indicated for these situations. • When administering medications, once the exposure or procedure is completed and exposure is no longer a danger, remove soiled protective garments or gear and perform hand hygiene. • Never remove, recap, cap, bend, or break any used needle 407 or needle system. Be sure to discard any disposable syringes and needles in the appropriate puncture-resistant container. • If you are unsure about a drug or dosage calculation, do not hesitate to double-check with a drug reference or with a pharmacist. DO NOT administer a medication if you are unsure about it! • Be punctual when giving drugs. Some medications must be given at regular intervals to maintain therapeutic blood levels. • Fig. 9.1 shows an example of an automated dispensing system. To prevent errors, obtain the drugs for one patient at a time. FIG. 9.1 Using an automated dispensing system 408 to remove medication. • Remember to check the drug at least three times before giving it. The nurse is responsible for checking original medication labels against the transcribed medication order. In Fig. 9.2, the nurse is checking the drug against the electronic medication administration record. The drug must then be checked before opening it and again after opening it but before giving it to the patient. Some high-alert drugs (i.e., insulin and intravenous [IV] heparin) must be checked by two licensed nurses. FIG. 9.2 Checking the medication against the order on the electronic medication administration record. • Health care facilities have various means of checking the medication record when a new medication order is received, so be sure that you are giving medications from a medication profile that has been checked or verified by the pharmacist before giving the medication. 409 • Check the expiration date of all medications. Medications used past the expiration date may be less potent or even harmful. • Make sure that drugs that are given together are compatible. For example, bile acid sequestrants and antacids (see Chapters 27 and 50) must not be given with other drugs, because they will interfere with drug absorption and action. Check with a pharmacist if unsure. Before administering any medication, check the patient's identification bracelet. The Joint Commission's standards require two patient identifiers (name and birthday, or name and account number, according to the facility's policy). In many health care facilities, patient information is in a barcode system that is scanned (Fig. 9.3). In addition, assess the patient's drug allergies before giving any medication. FIG. 9.3 The nurse is using a bar-code scanner to identify the patient before medication administration. Always check the patient's 410 identification, using two patient identifiers, and allergies before giving medications. • Be sure to take time to explain the purpose of each medication, its action, possible adverse effects, and any other pertinent information, especially drug-drug or drug-food interactions, to the patient and/or caregiver. • Open the medication at the bedside into the patient's hand or into a medicine cup. Try not to touch the drugs with your hands. Leaving the drugs in their packaging until you get to the patient's room helps avoid contamination and waste in case the patient refuses the drug. • If the patient refuses a drug, the drug may be returned to the automated medication dispenser or to the pharmacy if the package is unopened. Check facility policy. Discard opened drugs per protocol. Scheduled drugs that are not given will need a witness if discarded. Note on the patient's record which drug was refused and the patient's reason for refusal. • Discard any medications that fall to the floor or become contaminated by other means. • Stay with the patient while the patient takes the drugs. Do not leave the drugs on the bedside table or the meal tray for the patient to take later. • Always keep safety in mind when administering medications (Box 9.2). 411 Box 9.2 Safety and Medication Administration • Always verify the patient's correct identity, using two patient identifiers. • Always check for allergies to medications, foods, and other substances. • Always know the reason for the drug as well as the correct dose and administration technique. Follow the manufacturer's guidelines for preparation and delivery. • Always know the necessary assessments before giving the drug. • For antihypertensives, check the patient's blood pressure. • For insulin and other drugs that lower blood glucose levels, check the patient's blood glucose levels. • Know the patient's potassium levels before giving drugs that can change the level, such as oral supplements, corticosteroids, or ACE inhibitors. • Check the patient's apical pulse for one full minute before giving beta blockers, digoxin, or other drugs that cause bradycardia. • Assess the patient's CBC before administering chemotherapy. • Know the appropriate coagulation studies before administering anticoagulants. • Double-check calculations with a second nurse or a pharmacist—do the calculations independently and then compare results. • Remove and then administer medications from the automated dispensing cabinet for one patient at a time. • Follow the facility's protocol for verifying all medication orders (whether electronic or hand-written) before giving the medications. • For oral medications, ensure that the patient is able to swallow and has an intact gag reflex. For those with 412 difficulty swallowing, other routes may be necessary to avoid aspiration. • Use appropriate personal protective equipment as indicated. Use the safety device on used needles; then dispose into the proper container. Never recap used needles. • Administer medications via the prescribed route using correct technique. • Do not bypass the safety features of electronic pumps used to deliver medications, such as infusion pumps, smart pumps, PCA pumps. Workarounds can lead to serious errors. • Always verify correct placement of an enteral tube before giving medications. Watch the patient for signs of respiratory distress during medication administration through an enteral tube. • Monitor the patient for adverse effects and signs of allergic reactions after medications are given. • If a medication error or near miss incident occurs, report it per the facility's protocol. PCA, Patient-controlled analgesia. • Document the medication given on the medication record as soon as it is given and before going to the next patient. Be sure also to document therapeutic responses, adverse effects (if any), and other concerns in the nurse's notes. Many health care facilities now use electronic documentation, but manual documentation may still be used. • Return to evaluate the patient's response to the drug. Remember that the expected response time will vary according to the drug route. For example, responses to sublingual nitroglycerin or IV push medications need to be evaluated within 413 minutes, but it may take 1 hour or more for a response to be noted after an oral medication is given. Follow facility policy for reassessment after pain medication is given. • See Patient-Centered Care: Lifespan Considerations for the Pediatric Patient on p. 36 in Chapter 3 for age-related considerations for medication administration to infants and children. Enteral Drugs Administering Oral Drugs Always begin by performing hand hygiene and maintain Standard Precautions (see Box 9.1). When administering oral drugs, keep in mind the following points: Oral Medications • Administration of some oral medications (and medications by other routes) requires special assessments. For example, it is recommended that the apical pulse be auscultated for 1 full minute before any digitalis preparation is given (Fig. 9.4). Administration of other oral medications may require blood pressure monitoring. Be sure to document all parameters. In addition, do not forget to check the patient's identification and allergies before giving any oral medication (or medication by any other route). 414 FIG. 9.4 Some medications require special assessment before administration, such as taking an apical pulse. (Courtesy Rick Brady, Riva, MD.) • If the patient is experiencing difficulty swallowing (dysphagia), some types of tablets can be crushed with a pill-crushing device (Fig. 9.5) for easier administration. Crush one type of pill at a time, because if you mix together all of the medications before crushing (instead of crushing them one at a time) and then spill some, there is no way to know which drug has been wasted. Also, if all are mixed together, you cannot check the correct drug three times before giving the drug. Mix the crushed medication in a small amount of soft food, such as applesauce or pudding. Be sure that the pill-crushing device is clean before you use it, and clean it afterward. See Chapter 2 for more information on medications that are not to be crushed. 415 FIG. 9.5 Using a pill-crushing device to crush a tablet. (From Perry, A. G., & Potter, P. A. [2014]. Clinical nursing skills and techniques [8th ed.]. St Louis, MO: Mosby.) • CAUTION: Be sure to verify whether a medication can be crushed by consulting a drug reference book or a pharmacist. Some oral medications, such as capsules, enteric-coated tablets, and sustained-release or long-acting drugs, must not be crushed, broken, or chewed (Fig. 9.6). These medications are formulated to protect the gastric lining from irritation or protect the drug from destruction by gastric acids, or are designed to break down gradually and slowly release the medication. If these drugs, designated with labels such as sustained release or extended release, are crushed or opened, then the intended action of the dosage form is destroyed. As a result, gastric irritation may occur, the drug may be inactivated by gastric acids, or the immediate availability of a drug that was supposed to be released slowly may cause toxic effects. Check 416 with the prescriber to see if an alternate form of the drug is needed. FIG. 9.6 Enteric-coated tablets and long-acting medications are not to be crushed, broken, or chewed. (From Rick Brady, Riva, MD.) • Be sure to position the patient in a sitting or side-lying position to make it easier for him or her to swallow oral medications and to avoid the risk for aspiration (Fig. 9.7). Always provide aspiration prevention measures as needed. 417 FIG. 9.7 Giving oral medications. (From Rick Brady, Riva, MD.) • Offer the patient a full glass of water; 4 to 6 ounces of water or other fluid is recommended for the best dissolution and absorption of oral medications. Age-related considerations: Young patients and older adults may not be able to drink a full glass of water but need to take enough fluid to ensure that the medication reaches the stomach. If the patient prefers another fluid, be sure to check for interactions between the medication and the fluid of choice. If fluid restriction is ordered, be sure to follow the guidelines. • If the patient requests, you may place the pill or capsule in the patient's mouth with your gloved hand. • Oral lozenges need to be dissolved slowly in the mouth, and are not be chewed unless specifically instructed/ordered. • Effervescent powders and tablets need to be mixed with water and then given immediately 418 after they are dissolved. • Remain with the patient until all medication has been swallowed. If you are unsure whether a pill has been swallowed, ask the patient to open his or her mouth so that you can inspect to see if it is gone. Assist the patient to a comfortable position after the medication has been taken. • Document the medication given on the medication record, and monitor the patient for a therapeutic response as well as for adverse reactions. Sublingual and Buccal Medications The sublingual and buccal routes prevent destruction of the drugs in the gastrointestinal tract and allow for rapid absorption into the bloodstream through the oral mucous membranes. These routes are not often used. Be sure to provide instruction to the patient before giving these medications. • Sublingual tablets are placed under the tongue (Fig. 9.8). Buccal tablets are placed between the upper or lower molar teeth and the cheek. 419 FIG. 9.8 Proper placement of a sublingual tablet. (From Rick Brady, Riva, MD.) • Be sure to wear gloves if you are placing the tablet into the patient's mouth. Adhere to Standard Precautions (see Box 9.1). • Instruct the patient to allow the drug to dissolve completely before swallowing. • These drug forms are not taken with fluids. Instruct the patient not to drink anything until the tablet has dissolved completely. • Be sure to instruct the patient not to swallow the tablet; saliva should not be swallowed until the drug is dissolved. • When using the buccal route, alternate sides with each dose to reduce the risk for oral mucosa irritation. • Document the medication given on the medication record, and monitor the patient for a therapeutic response as well as for adverse reactions. Orally Disintegrating Medications 420 Orally disintegrating medications, either in tablet or medicated strip form, dissolve in the mouth without water within 60 seconds. These medications are placed on the tongue, not under the tongue, as in the sublingual route. The absorption through the oral mucosa is rapid with a faster onset of action than for drugs that are swallowed. The patient must be instructed to allow the medication to dissolve on the tongue and not to chew or swallow the medication. • Be sure to wear gloves if you are placing the medication on the patient's tongue. Adhere to Standard Precautions (see Box 9.1). • Make sure the patient has not eaten or had anything to drink for 5 minutes before and after taking these medications. • Orally disintegrating medications are often packed in foil blister packs. Do not open the package until just before giving the medication. Carefully open one dose at a time. These medications are fragile and may break if they are pushed through the blister pack. Once a blister or foil pack is opened, the tablet must either be taken or discarded; it cannot be stored for another time. • Orally disintegrating medications cannot be split, broken, or torn. • Instruct the patient to hold the medication on the tongue to allow it to dissolve, instead of chewing or swallowing it. This usually takes about 1 minute. Warn the patient that there may be a sweet or even slightly bitter taste. Remind the patient not to drink water or to eat for 5 minutes after taking the medication. 421 • Document the medication given on the medication record, and monitor the patient for a therapeutic response as well as for adverse reactions. Liquid Medications • Liquid medications may come in a single-dose (unit-dose) package, may be poured into a medicine cup from a multidose bottle, or may be drawn up in an oral-dosing syringe (Fig. 9.9). FIG. 9.9 (A) Liquid medication in a unit-dose package. (B) Liquid measured into a medicine cup. (C) Liquid medication in an oral-dosing syringe. • When pouring a liquid medication from a container, first shake the bottle gently to mix the contents if indicated. Remove the cap, and place it upside down on a paper towel on the counter. Hold the bottle with the label against the palm of your hand to keep any spilled medication from 422 altering the label. Place the medicine cup at eye level, and fill to the proper level on the scale (Fig. 9.10). Pour the liquid so that the base of the meniscus is even with the appropriate line measure on the medicine cup. FIG. 9.10 Measuring liquid medication at eye level. (From Rick Brady, Riva, MD.) • If you overfill the medicine cup, discard the excess in the sink. Do not pour it back into the multidose bottle. Before replacing the cap, wipe the rim of the bottle with a paper towel. • Doses of medications that are less than 5 mL cannot be measured accurately in a calibrated medicine cup. For small volumes, use a calibrated oral syringe. Do not use a hypodermic syringe or a syringe with a needle or syringe cap. If hypodermic syringes are used, the drug may be inadvertently given parenterally, or the syringe cap or needle, if not removed from the syringe, may become dislodged and accidentally aspirated 423 by the patient when the syringe plunger is pressed. • Document the medication given on the medication record, and monitor the patient for a therapeutic response as well as for adverse reactions. Oral Medications for Infants and Children • Liquids are usually ordered for infants and young children because they cannot swallow pills or capsules. • A plastic disposable oral-dosing syringe is recommended for measuring small doses of liquid medications. Use of an oral-dosing syringe prevents the inadvertent parenteral administration of a drug once it is drawn up into the syringe. • Position the infant so that the head is slightly elevated to prevent aspiration. Not all infants will be cooperative, and many need to be partially restrained (Fig. 9.11). 424 FIG. 9.11 Administering oral liquid medication to an infant. (Courtesy Oscar H. Allison, Jr. In Clayton, B. D., & Stock, Y. N. [2010]. Basic pharmacology for nurses [15th ed.]1 St. Louis, MO: Mosby.) • Place the plastic dropper or syringe inside the infant's mouth, beside the tongue, and administer the liquid in small amounts, while allowing the infant to swallow each time. • A clean empty nipple may be used to administer the medication. Place the liquid inside the empty nipple, and allow the infant to suck the nipple. Add a few milliliters of water to rinse any remaining medication into the infant's mouth, unless contraindicated. • Take great care to prevent aspiration. A crying infant can easily aspirate medication. If the infant is crying, wait until the infant is calmer before trying again to give the medication. • Do not add medication to a bottle of formula; the infant may refuse the feeding or may not drink all of it. Make sure that all of the oral medication 425 has been taken, and then return the infant to a safe, comfortable position. • A child will reject oral medications that taste bitter. The drug may be mixed with a teaspoon of a sweet-tasting food such as jelly, applesauce, ice cream, or sherbet. Using honey in infants is not recommended because of the risk for botulism. Do not mix the medication in an essential food item, such as formula, milk, or orange juice, because the child may reject that food later. After the medication is taken, offer the child juice, a flavored frozen ice pop, or water. Administering Drugs Through a Nasogastric or Gastrostomy Tube Always begin by performing hand hygiene and maintain Standard Precautions (see Box 9.1). Gloves must be worn. When administering drugs via these routes, keep in mind the following points: • Before giving drugs via these routes, position the patient in a semi-Fowler's or Fowler's position, and leave the head of the bed elevated for at least 30 minutes afterward to reduce the risk for aspiration (Fig. 9.12). 426 FIG. 9.12 Elevate the head of the bed before administering medications through a nasogastric or other enteric tube. • Assess whether fluid restriction or fluid overload is a concern. It will be necessary to give water along with the medications to flush the tubing. • Check to see if it is recommended for the drug to be given on an empty or full stomach. In addition, some drugs are incompatible with enteral feedings. If the drug is to be given on an empty stomach or if incompatibility exists, the feeding may need to be stopped before and/or after giving the medication. Follow the guidelines for the specific drug if this is necessary. Examples of drugs that are not compatible with enteral feedings are phenytoin and carbidopa-levodopa. • Whenever possible, give liquid forms of drugs to prevent clogging the tube. 427 • If tablets must be given, crush the tablets individually into a fine powder. Administer the drugs separately (Fig. 9.13). Keeping the drugs separate allows for accurate identification if a dose is spilled and avoids issues with drug incompatibility. Be sure to check whether the medication can be crushed; enteric-coated and sustained-release tablets or capsules are not to be crushed (see Chapter 2). Check with a pharmacist if you are unsure. FIG. 9.13 Medications given through gastric tubes need to be administered separately. Dilute crushed pills in 15 to 30 mL of water before administration. (From Rick Brady, Riva, MD.) • Before administering the drugs, follow facility policy for verifying tube placement and checking gastric residual. Reinstill gastric residual per facility policy, and then clamp the tube. • Dilute a crushed tablet or liquid medication in 15 to 30 mL of warm water. Some capsules may be opened and dissolved in 30 mL of warm water; check with a pharmacist. Do not add crushed medications directly to a gastric tube. • Remove the piston from an adaptable-tip 428 syringe, and attach the syringe to the end of the tube. Unclamp the tube, and pinch the tubing to close it again. Add 30 mL of warm water, and release the pinched tubing. Allow the water to flow in by gravity to flush the tube, and then pinch the tubing closed again before all the water is gone to prevent excessive air from entering the stomach. If a stopcock valve device is present on the enteral tube, then open and close the stopcock instead of pinching the tubing to clamp it. • Pour the diluted medication into the syringe and release the tubing to allow it to flow in by gravity (Fig. 9.14). Flush between each drug with 10 mL of warm water. Be careful not to spill the medication mixture. Adjust fluid amounts if fluid restrictions are ordered, but sufficient fluid must be used to dilute the medications and to flush the tubing. FIG. 9.14 Pour liquid medication into the syringe, then unclamp the tubing and allow it to flow in by gravity. (From Elkin, M. K., Perry, A. G., & Potter, P. A. [2004]. Nursing interventions and clinical skills [3rd ed.]. St. Louis, MO: Mosby.) 429 • If water or medication does not flow freely, you may apply gentle pressure with the plunger or bulb of the syringe. Do not try to force the medicine through the tubing. • After the last drug dose, flush the tubing with 30 mL of warm water, and then clamp the tube. Resume the tube feeding when appropriate. • Have the patient remain in a high Fowler or slightly elevated right-side-lying position to reduce the risk for aspiration. • Document the medications given on the medication record, the amount of fluid given on the patient's intake and output record, and the patient's response in the patient's record. Administering Rectal Drugs Always begin by performing hand hygiene and maintain Standard Precautions (see Box 9.1). Gloves must be worn. When administering rectal drugs, keep in mind the following points: • Assess the patient for the presence of active rectal bleeding or diarrhea, which generally are contraindications for the use of rectal suppositories. • Suppositories should not be divided to provide a smaller dose. The active drug may not be evenly distributed within the suppository base. • Position the patient on his or her left side, unless contraindicated. The uppermost leg needs to be flexed toward the waist (Sims position). Provide privacy and drape. 430 • Do not insert the suppository into stool. Gently palpate the rectal wall for the presence of feces. If possible, have the patient defecate. DO NOT palpate the patient's rectum if the patient has had rectal surgery. • Remove the wrapping from the suppository, and lubricate the rounded tip with water-soluble gel (Fig. 9.15). FIG. 9.15 Lubricate the suppository with a water- soluble lubricant. (From Rick Brady, Riva, MD.) • Insert the tip of the suppository into the rectum while having the patient take a deep breath and exhale through the mouth. With your gloved finger, quickly and gently insert the suppository into the rectum, against the rectal wall, at least 4 inches beyond the internal sphincter (Fig. 9.16). 431 FIG. 9.16 Inserting a rectal suppository. (Modified from Perry, A. G., & Potter, P. A. [2014]. Clinical nursing skills and techniques [8th ed.]. St. Louis, MO: Mosby.) • Have the patient remain lying on his or her left side for 15 to 20 minutes to allow absorption of the medication. • Age-related considerations: With children, it may be necessary to gently but firmly hold the buttocks in place for 5 to 10 minutes until the urge to expel the suppository has passed. Older adults with loss of sphincter control may not be able to retain the suppository. • If the patient prefers to self-administer the suppository, give specific instructions on the purpose and correct procedure. Be sure to tell the patient to remove the wrapper. • Use the same procedure for medications administered by a retention enema, such as sodium polystyrene sulfonate (see Chapter 29). Drugs given by enemas are diluted in the smallest amount of solution possible. Retention enemas need to be held for 30 minutes to 1 hour before expulsion, if possible, for maximum absorption. 432 • Document the medication given on the medication record, and monitor the patient for a therapeutic response as well as for adverse reactions. Parenteral Drugs Preparing for Parenteral Drug Administration Keep these in mind before administering parenteral drugs: • Fig. 9.17 illustrates the bevel of a needle. In some situations, such as intradermal (ID) injections, the bevel of the needle must be in the “up” position. FIG. 9.17 Close-up view of the bevel of a needle. (Courtesy Chuck Dresner.) • Fig. 9.18 illustrates the parts of a syringe and hypodermic needle. 433 FIG. 9.18 The parts of a syringe and hypodermic needle. • Be sure to choose the correct size and type of syringe for the drug and injection route ordered (Fig. 9.19). FIG. 9.19 (A) 10-mL syringe; (B) 5-mL syringe; (C) 3-mL syringe; (D) 1-mL tuberculin syringe; (E) 100-unit insulin syringe. • Syringes with needles have various devices to 434 prevent needlestick injuries. Fig. 9.20A shows a syringe with a barrel-type guard that slides up over the used needle until the guard locks into place. The syringe in Fig. 9.20B has a safety device that snaps over the needle after use. Always use these safety devices. FIG. 9.20 Syringes with needlestick prevention devices. (A) A guard protects the unused syringe, and (B) the guard is locked into place after use. • Some syringes, such as insulin syringes, have needles that are fixed to the syringe. After drawing up the insulin, it may be necessary to recap the UNUSED needle. In this situation, use the “scoop method” to recap the unused needle 435 safely. See Fig. 9.21. Be sure not to touch the needle to the countertop or to the outside of the needle cap. FIG. 9.21 Using the “scoop method” to recap an UNUSED needle safely for syringes with needles that are fixed to the syringe. • Needles come in various gauges and lengths (Fig. 9.22). The larger the gauge number, the smaller the needle. Be sure to choose the correct needle—gauge and length—for the type of injection ordered. 436 FIG. 9.22 Needles for injections come in various gauges and lengths. (From Rick Brady, Riva, MD.) • Some medications come in prefilled sterile medication cartridges. Fig. 9.23 show the Carpuject prefilled cartridge and syringe system. Follow the manufacturer's instructions for assembling prefilled syringes. After use, dispose of the syringe in a sharps container; the cartridge is reusable. Some prefilled syringes come with an air bubble in the syringe; do not expel the bubble before administration. 437 FIG. 9.23 The Carpuject prefilled cartridge and syringe system. (Both photos from Potter, P. A., & Perry, A. G. [1995]. Basic nursing: theory and practice [3rd ed.]. St. Louis, MO: Mosby.) • NEVER RECAP A USED NEEDLE! Always dispose of uncapped needles, and opened glass vials, in the appropriate sharps container (Fig. 9.24). See Box 9.1 for Standard Precautions. 438 FIG. 9.24 Disposing of a used needle and syringe into a sharps container. Removing Medications from Ampules Always begin by performing hand hygiene and maintain Standard Precautions (see Box 9.1). Gloves may be worn. When performing these procedures, keep in mind the following points: • When removing medication from an ampule, use a sterile filter needle (Fig. 9.25). These needles are designed to filter out glass particles that may be present inside the ampule after it is broken. The filter needle IS NOT intended for administration of the drug to the patient and must be removed before the medication is given to the patient. DO 439 NOT USE A FILTER NEEDLE FOR INJECTION INTO A PATIENT! Ampules containing medications come in various sizes (Fig. 9.26). The neck of the ampule must be broken carefully before the medication is withdrawn. Medication often rests in the top part of the ampule. Tap the top of the ampule lightly and quickly with your finger until all fluid moves to the bottom portion of the ampule (Fig. 9.27). FIG. 9.25 Using a filter needle when withdrawing medication from an ampule. Some health care facilities may also require the use of a filter needle to withdraw medications from a vial. 440 FIG. 9.26 Ampules containing medications come in various sizes. (From Potter, P. A., & Perry, A. G. [2001]. Fundamentals of nursing [5th ed.]. St. Louis, MO: Mosby.) FIG. 9.27 Tapping an ampule to move the fluid to below the neck. (From Rick Brady, Riva, MD.) • Place a small gauze pad or dry alcohol swab around the neck of the ampule to protect your hand. Snap the neck quickly and firmly, and break the ampule away from your body (Fig. 9.28A and B). 441 FIG. 9.28 Breaking an ampule. Carefully break the neck of the ampule (A) in a direction away from you and away from others near you (B). ([A] and [B] from Rick Brady, Riva, MD.) • To draw up the medication, either set the open ampule on a flat surface or hold the ampule upside down. Insert the filter needle (attached to a syringe) into the center of the ampule opening. Do not allow the needle tip or shaft to touch the rim of the ampule (Fig. 9.29). 442 FIG. 9.29 Using a filter needle to withdraw medication from an ampule. (From Rick Brady, Riva, MD.) • Gently pull back on the plunger to draw up the medication. Keep the needle tip below the fluid within the vial; tip the ampule to bring all of the fluid within reach of the needle. • If air bubbles are aspirated, do not expel them into the ampule. Remove the needle from the ampule, hold the syringe with the needle pointing up, and tap the side of the syringe with your finger to cause the bubbles to rise toward the needle. Draw back slightly on the plunger, and slowly push the plunger upward to eject the air. Do not eject fluid. • Excess medication is disposed of into a sink. Hold the syringe vertically with the needle tip up and slanted toward the sink. Slowly eject the excess fluid into the sink, and then recheck the fluid level by holding the syringe vertically. • Remove the filter needle, and replace with the 443 appropriate needle for administration. NEVER use a filter needle to administer medications to a patient! • Be sure to ensure the sterility of the injection needle throughout the process. Do not touch the open end of the needle hub, or the tip of the syringe, when attaching a needle to a syringe. • Dispose of the glass ampule pieces and the used filter needle in the appropriate sharps container. Removing Medications from Vials Always begin by performing hand hygiene and maintain Standard Precautions (see Box 9.1). Gloves may be worn. When performing these procedures, keep in mind the following points: • Vials can contain either a single dose or multiple doses of medication. Follow facility policy for using opened multidose vials, such as vials of insulin. Mark multidose vials with the date and time of opening and the discard date (per facility policy). If you are unsure about the age of an opened vial of medication, discard it and obtain a new one. • Check facility policy regarding which type of needle to use to withdraw fluid from a vial. With the exception of insulin, which must be withdrawn using an insulin syringe, fluid may be withdrawn from a vial using a blunt fill needle or a filter needle. Using a blunt fill needle (Fig. 9.30) or needleless system reduces the risk for injury with a sharp needle. 444 FIG. 9.30 Comparison of the sharp tip of a needle for injection (A) with the blunt tip of a fill needle (B), which is used to remove fluid from a vial. • If the vial is unused, remove the cap from the top of the vial. • Always wipe the top of the vial vigorously with an alcohol swab, whether the vial has been previously used or if you have just removed the cap. • Air must first be injected into a vial before fluid can be withdrawn. The amount of air injected into a vial needs to equal the amount of fluid that needs to be withdrawn. • Determine the volume of fluid to be withdrawn from the vial. Pull back on the syringe's plunger to draw an amount of air into the syringe that is equivalent to the volume of medication to be removed from the vial. Insert the syringe into the vial, preferably using a blunt fill needle. Inject the air into the vial (Fig. 9.31). 445 FIG. 9.31 Insert air into a vial before withdrawing medication. • While holding onto the plunger, invert the vial and remove the desired amount of medication (Fig. 9.32). FIG. 9.32 Withdrawing medication from a vial. • Gently but firmly tap the syringe to remove air bubbles. Excess fluid, if present, must then be discarded into a sink. 446 • When an injection requires two medications from two different vials, begin by injecting air into the first vial (without touching the fluid in the first vial), and then inject air into the second vial. Immediately remove the desired dose from the second vial. Change needles (if possible), and then remove the exact prescribed dose of drug from the first vial. Take great care not to contaminate the drug in one vial with the drug from the other vial. Check with a pharmacist to make sure the two drugs are compatible for mixing in the same syringe. • For injections, if a needle has been used to remove medication from a vial, always change the needle before administering the dose. Changing needles ensures that a clean and sharp needle is used for the injection. Medication that remains on the outside of the needle may cause irritation to the patient's tissues. In addition, the needle may become dull if used to puncture a rubber stopper. However, some syringes, such as insulin syringes, have needles that are fixed onto the syringe and cannot be removed. • Ensure the sterility of the injection needle throughout the process. Do not touch the open end of the needle hub, or the tip of the syringe, when attaching a needle to a syringe. Injections Overview Needle Insertion Angles for Intramuscular, 447 Subcutaneous, and Intradermal Injections • For any injection, if syringes are prepared at a medication cart or in a medication room, then each parenteral medication should be prepared separately and a label identifying the patient, medication, dose, and route placed on the barrel of the syringe before the nurse leaves the preparation area. • For intramuscular (IM) injections, insert the needle at a 90-degree angle (Fig. 9.33). IM injections deposit the drug deep into muscle tissue, where the drug is absorbed through blood vessels within the muscle. The rate of absorption of medications given by the IM route is slower than that of medications given by the IV route but faster than that of medications given by the subcutaneous (subQ) route. IM injections generally require a longer needle to reach the muscle tissue, but shorter needles may be needed for older patients, children, and adults who are malnourished. The site chosen will also determine the length of the needle needed. In general, aqueous medications can be given with a 20- to 25gauge needle, but oil-based or more viscous (thick) medications are given with an 18- to 21gauge needle. Average needle lengths for children range from to 1 inch, and needles for adults range from 1 to inches. The nurse must choose the needle length based on the size of the muscle at the injection site, the age of the patient, and the 448 type of medication used. For a normal, welldeveloped adult, 3 mL is the maximum amount used in a single injection. Follow facility policy. If more than 3 mL is needed for the ordered dose, then the medication will need to be given in two separate injections. However, if the patient is an older adult or is thin, a smaller maximum volume, such as 2 mL, is recommended. FIG. 9.33 Comparison of angles of needle insertion for injections. (From Perry, A. G., & Potter, P. A. [2014]. Clinical nursing skills and techniques [8th ed.]. St. Louis, MO: Mosby.) • For subQ injections, insert the needle at either a 45- or 90-degree angle (see Fig. 9.33). SubQ injections deposit the drug into the loose connective tissue under the dermis. This tissue is not as well supplied with blood vessels as is the muscle tissue; as a result, drugs are absorbed more slowly than drugs given intramuscularly. Doses are usually 0.5 to 1 mL. In general, use a 25-to 27gauge, - to -inch needle. A 90-degree angle is used for an average-sized patient; a 45-degree angle may be used for thin, emaciated, and/or malnourished adults and for children. To ensure correct needle 449 length, grasp the skinfold with thumb and forefinger, and choose a needle that is approximately half the length of the skinfold from top to bottom. • ID injections are given into the outer layers of the dermis in very small amounts, usually 0.01 to 0.1 mL. These injections are used mostly for diagnostic purposes, such as testing for allergies or tuberculosis, and for local anesthesia. Very little of the drug is absorbed systemically. In general, choose a tuberculin or 1-mL syringe with a 25- or 27-gauge needle that is to inches long. The angle of injection is 5 to 15 degrees (see Fig. 9.33). • For specific information about giving injections to children, see Box 9.3. Box 9.3 Pediatric Injections Site selection is crucial for pediatric injections. Factors to consider are the age of the child, the size of the muscle at the injection site, the type of injection, the thickness of the solution, and the ease with which the child can be positioned properly. There is no universal agreement in the literature on the “best” IM injection site for children. For infants, the preferred site is the vastus lateralis muscle. The ventrogluteal site may also be used in children of all ages. For immunizations in toddlers and older children, the deltoid muscle may be used if the muscle mass is well developed. IM injections for older infants and small children should not exceed 1 mL in a single injection. Refer to health care facility policy. Children are often extremely fearful of needles and 450 injections. Even a child who appears calm may become upset and lose control during an injection procedure. For safety reasons, it is important to have another person available for positioning and holding the child. Distraction techniques are helpful. Say to the child, “If you feel this, you can ask me to take it out, please.” Be quick and efficient when giving the injection. Have a small, colorful bandage on hand to apply after the injection. If the child is old enough, have the child hold the bandage and apply it after the injection. If possible, offer a reward sticker after the injection. After the injection, allow the child to express his or her feelings. For young children, encourage parents to offer comfort with holding and cuddling. Older children respond better if they receive praise. EMLA (lidocaine/prilocaine) cream or a vapocoolant spray, if available, may be used before the injection to reduce the pain from the needle insertion. However, because these agents do not absorb down into the muscle, the child may still experience pain when the medication enters the muscle. Apply EMLA cream to the site at least 1 hr and up to 3 hr before the injection. Vapocoolant spray is applied to the site immediately before the injection. Another option is to apply a wrapped ice cube to the injection site for 1 min before the injection. Air-Lock Technique • Some health care facilities recommend administering IM injections using the air-lock technique (Fig. 9.34). 451 FIG. 9.34 Air-lock technique for intramuscular injections. (From Elkin, M. K., Perry, A. G., & Potter, P. A. [2004]. Nursing interventions and clinical skills [3rd ed.]. St. Louis, MO: Mosby.) • After withdrawing the desired amount of medication into the syringe, withdraw an additional 0.2 mL of air. Be sure to inject using a 90-degree angle. The small air bubble that follows the medication during the injection may help prevent the medication from leaking through the needle track into the subQ tissues. Intradermal Injections Always begin by performing hand hygiene and maintain Standard Precautions (see Box 9.1). Gloves must be worn. When giving an ID injection, keep in mind the following points: • Be sure to choose an appropriate site for the injection. Avoid areas of bruising, rashes, inflammation, edema, or skin discoloration. • Help the patient to a comfortable position. Extend and support the elbow and forearm on a flat surface. 452 • In general, three to four finger widths below the antecubital space and one hand width above the wrist are the preferred locations on the forearm. Areas on the back that are also suitable for subQ injection may be used if the forearm is not appropriate for the ID injection. • Cleanse the site with an alcohol or antiseptic swab. Apply the swab at the center of the site, and cleanse outward in a circular direction for about 2 inches (5 cm; see Fig. 9.37); then let the skin dry. • After cleansing the site, stretch the skin over the site with your nondominant hand. • With the needle almost against the patient's skin, insert the needle, bevel UP, at a 5- to 15-degree angle until resistance is felt, and then advance the needle through the epidermis, approximately 3 mm. The needle tip should still be visible under the skin. • Do not aspirate. This area under the skin contains very few blood vessels. • Slowly inject the medication. It is normal to feel resistance, and a bleb that resembles a mosquito bite (about 6 mm in diameter) will form at the site if accurate technique is used (Fig. 9.35). 453 FIG. 9.35 Intradermal injection. (From Perry, A. G., Potter, P. A., & Ostendorf, W. [2018]. Clinical nursing skills & techniques [9th ed.]. St. Louis, MO: Mosby.) • Withdraw the needle slowly while gently applying a dry gauze pad at the site, but do not massage the site. • Dispose of the syringe and needle in the appropriate container. Use the safety device to cover the used needle. DO NOT RECAP the needle. Perform hand hygiene after removing gloves. • Provide instructions to the patient as needed for a follow-up visit for reading the skin testing, if applicable. • Document on the medication record the date of the skin testing and the date that results need to be read, if applicable. Subcutaneous Injections Always begin by performing hand hygiene and maintain Standard Precautions (see Box 9.1). Gloves must be worn. When giving a subQ injection, keep in mind the following points: 454 • Be sure to choose an appropriate site for the injection (Fig. 9.36). Avoid areas of bruising, rashes, inflammation, edema, or skin discoloration. FIG. 9.36 Potential sites for subcutaneous injections. (From Perry, A. G., & Potter, P. A. [2014]. Clinical nursing skills and techniques [8th ed.]. St. Louis, MO: Mosby.) • Ensure that the needle size is correct. Grasp the skinfold between your thumb and forefinger, and measure from top to bottom. The needle must be approximately one-half this length. • Cleanse the site with an alcohol or antiseptic swab. Apply the swab at the center of the site, and cleanse outward in a circular direction for about 2 inches (5 cm; Fig. 9.37); then let the skin dry. 455 FIG. 9.37 Before giving an injection, cleanse the skin with an alcohol or antiseptic swab using a circular motion. • Tell the patient that he or she will feel a “stick” as you insert the needle. • For an average-sized patient, pinch the skin with your nondominant hand and inject the needle quickly at a 45- or 90-degree angle (Fig. 9.38). FIG. 9.38 Giving a subcutaneous injection at a 90-degree angle. • For an obese patient, pinch the skin and inject 456 the needle at a 90-degree angle. Be sure the needle is long enough to reach the base of the skinfold. • Age-related considerations: For a child or a thin patient, pinch the skin gently and be sure to use a 45-degree angle when injecting the needle. • Injections given in the abdomen must be given at least 2 inches away from the umbilicus because of the surrounding vascular structure (Fig. 9.39). The injection site must also be 2 inches away from any incisions, stomas, or open wounds, if present. FIG. 9.39 When giving a subcutaneous injection in the abdomen, be sure to choose a site at least 2 inches away from the umbilicus. • After the needle enters the skin, grasp the lower end of the syringe with your nondominant hand. Move your dominant hand to the end of the plunger—be careful not to move the syringe. • Aspiration of medication to check for blood return is not necessary for subQ injections, but some facilities may require it. Check facility 457 policy. Heparin injections and insulin injections are NOT aspirated before injection. • With your dominant hand, slowly inject the medication. • Withdraw the needle quickly, and place a swab or sterile gauze pad over the site. • Apply gentle pressure, but do not massage the site. If necessary, apply a bandage to the site. • Use the safety device to cover the needle. Dispose of the syringe and needle in the appropriate container. DO NOT RECAP the needle. Perform hand hygiene after removing gloves. • Document the medication given on the medication record, and monitor the patient for a therapeutic response as well as for adverse reactions. • For injections of heparin or other subQ anticoagulants, follow the manufacturer's instructions for injection technique as needed. Many manufacturers recommend the area of the abdomen known as the “love handles” for injection of anticoagulants. DO NOT ASPIRATE before injecting, and DO NOT MASSAGE the site after injection. These actions may cause a hematoma at the injection site. • The air bubble should not be expelled from prefilled syringes, as this is designed to remain next to the plunger to ensure the whole dose is administered. 458 • Heparin doses are ordered in units, but it is important to note that units of heparin are not the same as units of insulin. Heparin is never measured with an insulin syringe. Insulin Syringes • Always use an insulin syringe to measure and administer insulin. A unit of insulin is NOT equivalent to a milliliter of insulin! Fig. 9.40A shows a U-100 syringe, used for U-100 insulins; each line represents 2 units. Fig. 9.40B shows a U500 insulin syringe; each line measures 5 units of U-500 insulin. Note: Always use a U-500 insulin syringe to draw up U-500 insulin; otherwise, severe insulin overdoses may occur (see Chapter 32). FIG. 9.40 Insulin syringes are available in U-100 (A) and U-500 (B) calibrations. 459 • Fig. 9.41 shows examples of insulin pens used to help the patient self-administer insulin. These pens feature a multidose container of insulin and easy-to-read dials for choosing the correct dose. The needle is changed with each use. These devices are for single-patient use only and must never be used by more than one patient due to the risk for blood contamination of the medication reservoir. See the box Safety and Quality Improvement: Preventing Medication Errors Insulin Pens are for Single-Patient Use Only. FIG. 9.41 Examples of prefilled insulin pens for insulin injections. • When two different types of insulin are drawn up into the same syringe, always draw up the rapid-acting or short-acting (clear) insulin into the syringe first (Fig. 9.42). See p. 113 for information about mixing two different medications in one syringe. 460 FIG. 9.42 Mixing two types of insulin in the same syringe. NOTE: The rapid- or short-acting (clear) insulin is always drawn up into the syringe first. (From Perry, A. G., & Potter, P. A. [2014]. Clinical nursing skills and techniques [8th ed.]. St. Louis, MO: Mosby.) Safety and Quality Improvement: Preventing Medication Errors Insulin Pens Are for Single-Patient Use Only The Institute for Safe Medication Practices (ISMP) has received numerous reports of hospital staff using a single insulin pen for multiple patients. It is thought that there is a widespread misunderstanding that sterility can be maintained between patients by using a fresh, sterile needle on the pen device for each use. However, several studies have reported that the possibility of cross-contamination exists when a single pen is used for multiple patients. Blood may be pulled inside the insulin cartridge after an injection, resulting in a risk of pathogen transmission from one patient to another. Insulin pens are intended for use for a single patient, with a new needle for each injection. They are not to be used for more than one patient, even with a new needle. If insulin pens are used in the inpatient setting, they must be labeled with a specific patient's information in a manner that does not cover the 461 drug name, and only used for that patient. However, due to ongoing problems with insulin pens in the hospital setting, the ISMP has recommended that hospitals consider moving away from using these pens. For more information, see the Centers for Disease Control and Prevention's clinical reminder at www.cdc.gov/injectionsafety/clinicalreminders/insulin-pens.html. Also see the ISMP website at www.ismp.org/newsletters/acutecare/showarticle.aspx?id=41. (Accessed August 21, 2017.) Intramuscular Injections Always begin by performing hand hygiene and maintain Standard Precautions (see Box 9.1). Gloves must be worn. When giving an IM injection, keep in mind the following points: • Choose the appropriate site for the injection by assessing not only the size and integrity of the muscle but the amount and type of injection. Palpate potential sites for areas of hardness or tenderness, and note the presence of bruising or infection. • The dorsogluteal injection site is no longer recommended for injections because of the close proximity to the sciatic nerve and major blood vessels. Injury to the sciatic nerve from an injection may cause partial paralysis of the leg. The dorsogluteal site is not to be used for IM injections; instead, the ventrogluteal site is the preferred IM injection site for adults and children. • Assist the patient to the proper position, and ensure his or her comfort. • Locate the proper site for the injection. Cleanse the site with an alcohol or antiseptic swab. Apply 462 the swab at the center of the site, and cleanse outward in a circular direction for about 2 inches (5 cm; see Fig. 9.37); then let the skin dry. Keep a sterile gauze pad nearby for use after the injection. • With your nondominant hand, pull the skin taut. Follow the instructions for the Z-track method (see p. 118) if appropriate. • Grasp the syringe with your dominant hand as if holding a dart, and position the needle at a 90degree angle to the skin. Tell the patient that he or she will feel a “stick” as you insert the needle. • Insert the needle quickly and firmly into the muscle. Grasp the lower end of the syringe with the nondominant hand while still holding the skin back, to stabilize the syringe. With the dominant hand, pull back on the plunger for 5 to 10 seconds to check for blood return. • If no blood appears in the syringe, inject the medication slowly, at the rate of 1 mL every 10 seconds. After injecting the drug, wait 10 seconds, and then withdraw the needle smoothly while releasing the skin. • Apply gentle pressure at the site, and watch for bleeding. Apply a bandage if necessary. • If blood does appear in the syringe, remove the needle, dispose of the medication and syringe, and prepare a new syringe with the medication. • Use the safety device to cover the needle. Dispose of the syringe and needle in the appropriate container. DO NOT RECAP the 463 needle. Perform hand hygiene after removing gloves. • Document the medication given on the medication record, and monitor the patient for a therapeutic response as well as for adverse reactions. Z-Track Method • The Z-track method is used for injections of irritating substances such as iron dextran and hydroxyzine. The technique reduces pain, irritation, and staining at the injection site. Some health care facilities recommend this method for all IM injections (Fig. 9.43). FIG. 9.43 Z-track method for intramuscular 464 injections. (From Perry, A. G., & Potter, P. A. [2014]. Clinical nursing skills and techniques [8th ed.]. St. Louis, MO: Mosby.) • After choosing and preparing the site for injection, use your nondominant hand to pull the skin laterally, and hold it in this position while giving the injection. Insert the needle at a 90degree angle, aspirate for 5 to 10 seconds to check for blood return, and then inject the medication slowly. After injecting the medication, wait 10 seconds before withdrawing the needle. Withdraw the needle slowly and smoothly, and maintain the 90-degree angle. • Release the skin immediately after withdrawing the needle to seal off the injection site. This technique forms a Z-shaped track in the tissue that prevents the medication from leaking through the more sensitive subQ tissue from the muscle site of injection. Apply gentle pressure to the site with a dry gauze pad. Ventrogluteal Site • The ventrogluteal site is the preferred site for adults and children. It is considered the safest of all sites because the muscle is deep and away from major blood vessels and nerves (Fig. 9.44). 465 FIG. 9.44 Finding landmarks for a ventrogluteal injection. (Modified from Potter, P. A., & Perry, A. G. [1993]. Fundamentals of nursing: Concepts, process, and practice [3rd ed.]. St. Louis, MO: Mosby.) • Position the patient on his or her side, with knees bent and upper leg slightly ahead of the bottom leg. If necessary, the patient may remain in a supine position. • Palpate the greater trochanter at the head of the femur and the anterosuperior iliac spine. As illustrated in Fig. 9.44, use the left hand to find landmarks when injecting into the patient's right ventrogluteal site, and use the right hand to find landmarks when injecting into the patient's left ventrogluteal site. Place the palm of your hand over the greater trochanter and your index finger on the anterosuperior iliac spine. Point your thumb toward the patient's groin and fingers toward the patient's head. Spread the middle finger back along the iliac crest, toward the buttocks, as much as possible. • The injection site is the center of the triangle formed by your middle and index fingers (see arrow in Fig. 9.45A). 466 FIG. 9.45 Ventrogluteal intramuscular injection. • Give the injection (see Fig. 9.45B), following the general instructions for giving an injection. Before giving the injection, you may need to switch hands so that you can use your dominant hand to give the injection. Vastus Lateralis Site • Generally the vastus lateralis muscle is well developed and not located near major nerves or blood vessels. It is the preferred site of injection of 467 drugs such as immunizations for infants and small children (Fig. 9.46). For specific information about giving injections to children, see Box 9.3. FIG. 9.46 Vastus lateralis intramuscular injection in a small child. The nurse stabilizes the leg before giving the injection. (From Hockenberry, M. J., & Wilson, D. [2011]. Wong's nursing care of infants and children [9th ed.]. St. Louis, MO: Mosby.) • The patient may be sitting or lying supine; if supine, have the patient bend the knee of the leg in which the injection will be given. • To find the correct site of injection, place one hand above the knee and one hand below the greater trochanter of the femur. Locate the midline of the anterior thigh and the midline of the lateral side of the thigh. The injection site is located within the rectangular area (Figs. 9.47 and 9.48A and B). 468 FIG. 9.47 Finding landmarks for a vastus lateralis intramuscular injection. (Modified from Potter, P. A., Perry, A. G. [1993]. Fundamentals of nursing: Concepts, process, and practice [3rd ed.]. St. Louis, MO: Mosby.) FIG. 9.48 Vastus lateralis intramuscular injection. 469 Deltoid Site • Even though the deltoid site (Fig. 9.49) is easily accessible, it is not the first choice for IM injections because the muscle may not be well developed in some adults, and the site carries a risk for injury because the axillary nerve lies beneath the deltoid muscle. In addition, the brachial artery and radial, brachial, and ulnar nerves are also located in the upper arm. Always check medication administration policy, because some heath care facilities do not permit the use of the deltoid site for IM injections. The deltoid site must only be used for administration of immunizations to toddlers, older children, and adults (not infants) and only for small volumes of medication (0.5 to 1 mL). 470 FIG. 9.49 Finding landmarks for a deltoid intramuscular injection. (Modified from Potter, P. A., & Perry, A. G. [1993]. Fundamentals of nursing: Concepts, process, and practice [3rd ed.]. St. Louis, MO: Mosby.) • The patient may be sitting or lying down. Remove clothing to expose the upper arm and shoulder; do not roll up tight-fitting sleeves. Have the patient relax his or her arm and slightly bend the elbow. • Palpate the lower edge of the acromion process. This edge becomes the base of an imaginary triangle (Fig. 9.50A). 471 FIG. 9.50 Deltoid intramuscular injection. The deltoid site is not considered a primary site for intramuscular injections but is used for immunizations for toddlers, older children, and adults. This site is not used for infants. (Both photos from Rick Brady, Riva, MD.) • Place three fingers below this edge of the acromion process. Find the point on the lateral arm in line with the axilla. The injection site will be in the center of this triangle, three finger widths (1 to 2 inches) below the acromion process. • Age-related considerations: In children and smaller adults, it may be necessary to bunch the underlying tissue together before giving the injection and/or use a shorter ( -inch) needle (see Fig. 9.50B). 472 • To reduce patient anxiety, have the patient look away before giving the injection. Preparing Intravenous Medications Always begin by performing hand hygiene and maintain Standard Precautions (see Box 9.1). Gloves must be worn for most of these procedures. When administering IV drugs, keep in mind the following points: • The IV route for medication administration provides for rapid onset and faster therapeutic drug levels in the blood than other routes. However, the IV route is also potentially more dangerous. Once an IV drug is given, it begins to act immediately and cannot be removed. The nurse must be aware of the drug's intended effects and possible adverse effects. In addition, hypersensitivity (allergic) reactions may occur quickly. • Many facilities now use a needleless system for all infusion lines. • Before giving an IV medication, assess the patient for drug allergies, assess the IV line for patency, and assess the site for signs of phlebitis or infiltration. • When more than one IV medication is to be given, check with the pharmacy for compatibility if the medications are to be infused at the same time. • Check the expiration date of both the medication and infusion bags. 473 • Age-related considerations: For children, infusion pumps must be used to prevent the risk for infusing the fluid and medication too fast. • The Joint Commission requires that the pharmacy prepare IV solutions and IV piggyback (IVPB) admixtures under a special laminar airflow hood. On the rare occasion when you must dilute a drug for IV use, contact the pharmacist for instructions. Be sure to verify which type of fluid to use and the correct amount of solution for the dosage. • Nurses must receive special training and certification before administering chemotherapy drugs. • It is important to choose the correct solution for diluting IV medications. For example, phenytoin must be infused with normal saline (NS), not dextrose solutions (see Chapter 14). Check with the pharmacist if necessary. • Most IVPB medications come in vials that are added to the IV bag just before administration. This “add-a-vial” system allows the IV medication vial to be attached to a small-volume minibag for administration. Fig. 9.51 shows two examples of IVPB medications attached to small-volume infusion bags. 474 FIG. 9.51 Two types of intravenous (IV) piggyback medication delivery systems. These IV systems must be activated before the drug is administered to the patient. (From Rick Brady, Riva, MD.) • These IVPB medication setups allow for mixing of the drug and diluent immediately before the medication is given. Remember that if the seals are not broken and the medication is not mixed with the fluid in the infusion bag, then the medication stays in the vial! As a result, the patient does not receive the ordered drug dose; instead, the patient receives a small amount of plain IV fluid. • One type of IVPB system that needs to be activated before administration is illustrated in Fig. 9.52. To activate this type of IVPB system, snap the connection area between the IV infusion bag and the vial (Fig. 9.53). Gently squeeze the fluid from the infusion bag into the vial, and allow the medication to dissolve. After a few minutes, rotate the vial gently to ensure that all of the powder is dissolved. When the drug is fully dissolved, hold the IVPB apparatus by the vial and 475 squeeze the bag; fluid will enter the bag from the vial (Fig. 9.54). Make sure that all of the medication is returned to the IVPB bag. FIG. 9.52 Activating an intravenous piggyback infusion bag (step 1). (From Rick Brady, Riva, MD.) FIG. 9.53 Activating an intravenous piggyback infusion bag (step 2). (From Rick Brady, Riva, MD.) 476 FIG. 9.54 Activating an intravenous piggyback infusion bag (step 3). (From Rick Brady, Riva, MD.) • When hanging these IVPB medications, take care NOT to squeeze the bag. This may cause some of the fluid to leak back into the vial and alter the dose given. • Always label the IVPB bag with the patient's name and room number, the name of the medication, the dose, the date and time mixed, your initials, and the date and time the medication was given. Many pharmacies will provide a printed label with this information. • Some IV medications must be mixed using a needle and syringe. Again, in many facilities, this procedure will be performed in the pharmacy. After checking the order and the compatibility of the drug and the IV fluid, wipe the port of the IV bag with an alcohol swab (Fig. 9.55A). 477 478 FIG. 9.55 Adding a medication to an intravenous infusion bag with a needle and syringe. (From Rick Brady, Riva, MD.) • Carefully insert the needle into the center of the port, and inject the medication (see Fig. 9.55B and C). Note how the medication remains in the lower part of the IV infusion bag. Turn the bag gently, end to end, to mix the fluid and added medication (Fig. 9.56). 479 FIG. 9.56 Note how the intravenous medication is concentrated at the bottom of the bag. Always mix the medication thoroughly before infusing by gently turning the bag end to end. Do not shake the bag. (From Rick Brady, Riva, MD.) • Always add medication to a new bag of IV fluid, not to a bag that has partially infused. The concentration of the medication may be too strong if it is added to a partially full bag. • Always label the IV infusion bag when a drug has been added (Fig. 9.57). Label as per facility policy, and include the patient's name and room number, the name of the medication, the date and time mixed, your initials, and the date and time the infusion was started. In addition, label all IV infusion tubing per facility policy. 480 FIG. 9.57 Label the intravenous infusion bag when medication has been added. (From Rick Brady, Riva, MD.) Infusions of Intravenous Piggyback Medications Always begin by performing hand hygiene and maintain Standard Precautions (see Box 9.1). Gloves must be worn. • Refrigerated medications may need to be left on the counter to warm to room temperature before administering. If you are infusing the IVPB medication for the first time, you will need to attach the medication bag to the appropriate tubing and “prime” the tubing by allowing just enough fluid through the tubing to flush out the air. Take care not to waste too much of the medication when flushing the tubing. • If you are adding IVPB medication to an infusion that already has tubing, then use the 481 technique of “backpriming” to flush the tubing. Backpriming allows for the administration of multiple IV medications without multiple disconnections, and thus reduces the risk for contamination of the IV tubing system. Backpriming also removes the old medication fluid that has remained in the IVPB tubing from the previous dose of IV medication. • After ensuring that the medication in the primary infusion (if any) is compatible with the medication in the IVPB bag, close the roller clamp on the primary infusion if the IV fluid is infusing by gravity flow (not necessary if an infusion pump is used). Remove the empty IVPB container from the IV pole, lower it to below the level of the primary infusion bag, and open the clamp on the IVPB tubing (Fig. 9.58). This will allow fluid to flow from the primary IV bag into the empty IVPB bag. Then close the clamp on the IVPB tubing, and squeeze the fluid that is in the drip chamber into the old IVPB bag to remove the old medication fluid. At this point, you may add the new dose of IV medication to the IVPB tubing. 482 FIG. 9.58 Using the backpriming method to flush the intravenous (IV) piggyback (secondary) tubing. Fluid is drained through the tubing into the old IV piggyback bag, which is then discarded. The new dose of medication is then attached to the primed secondary tubing. • Backpriming will not be possible if the primary IV infusion contains heparin, aminophylline, a vasopressor, or multivitamins. Check with a pharmacist if unsure about compatibility. • Stopping IV infusions of medications such as vasopressors for an IVPB medication may affect a patient's blood pressure; stopping IV heparin may affect the patient's coagulation levels. Be sure to assess carefully before adding an IVPB medication to an existing infusion. A separate IV line may be 483 necessary so that the primary infusion is not stopped for the IVPB. • Fig. 9.59 shows an IVPB medication infusion (also known as the secondary infusion) with a primary gravity infusion. When the IVPB bag is hung higher than the primary IV infusion bag, the IVPB medication will infuse until empty, and then the primary infusion will take over again. FIG. 9.59 Infusing an intravenous piggyback (IVPB) medication with a primary gravity infusion. Note how the primary bag is lower than the IVPB. (From Potter, P. A., Perry, A. G., Stockert, P. A., et al. [2013]. Fundamentals of nursing [8th ed.]. St. Louis, MO: 484 Mosby.) • When beginning the infusion, attach the IVPB tubing to the upper port on the primary IV tubing. A back-check valve above this port prevents the medication from infusing up into the primary IV infusion bag. • Fully open the clamp of the IVPB tubing, and regulate the infusion rate with the roller clamp of the primary infusion tubing. Be sure to note the drip factor of the tubing, and calculate the drops per minute to set the correct infusion rate for the IVPB medication. • Monitor the patient during the infusion. Observe for hypersensitivity and for adverse reactions. In addition, observe the IV infusion site for infiltration. Have the patient report if pain or burning occurs. • Monitor the rate of infusion during the IVPB medication administration. Changes in arm position may alter the infusion rate. • When the infusion is complete, clamp the IVPB tubing and check the primary IV infusion rate. If necessary, adjust the clamp to the correct infusion rate. • Fig. 9.60 shows an IVPB medication infusion with a primary infusion that is going through an electronic infusion pump. 485 FIG. 9.60 Infusing an intravenous piggyback medication with the primary infusion on an electronic (smart) infusion pump. • When giving IVPB drugs through an IV infusion controlled by a pump, attach the IVPB tubing to the port on the primary IV tubing above the pump. Open the roller clamp of the IVPB medication tubing. Make sure that the IVPB bag is higher than the primary IV infusion bag. • Following the manufacturer's instructions, set the infusion pump to deliver the IVPB medication. Entering the volume of the IVPB bag and the desired time frame of the infusion (e.g., over a 60minute period) will cause the pump to automatically calculate the flow rate for the IVPB 486 medication. Start the IVPB infusion as instructed by the pump. • Monitor the patient during the infusion, as described earlier. • When the infusion is complete, the primary IV infusion will automatically resume. • Document the medication given on the medication record, and monitor the patient for a therapeutic response as well as for adverse reactions. • When giving IV medications through a saline lock, follow facility policy for the flushing protocol before and after the medication is administered. • Fig. 9.61 illustrates a volume-controlled administration set that can be used to administer IV medications. The chamber is attached to the infusion between the IV infusion bag and the IV tubing. Fill the chamber with the desired amount of fluid, and then add the medication via the port above the chamber, as shown in the photo. Be sure to cleanse the port with an alcohol swab before inserting the needle in the port. Label the chamber with the medication's name, dose, and time added, and your initials. Infuse the drug at the prescribed rate. 487 FIG. 9.61 Adding a medication to a volume- controlled administration set. (From Potter, P. A., & Perry, A. G. [2005]. Fundamentals of nursing [6th ed.]. St. Louis, MO: Mosby.) • In patient-controlled analgesia (PCA), a specialized pump is used to allow patients to selfadminister pain medications, usually opiates (Fig. 9.62). These pumps allow the patient to selfadminister only as much medication as needed to control the pain by pushing a button for IV bolus doses. Safety features of the pump prevent accidental overdoses. A patient receiving PCA pump infusions must be monitored closely for his or her response to the drug, excessive sedation, respiratory depression, hypotension, and changes in mental status. End-tidal CO2 is often monitored. Follow facility policy for setup and use. 488 FIG. 9.62 Instructing the patient on the use of a patient-controlled analgesia pump. • Fig. 9.63 displays a smart pump, an IV infusion safety system that has been designed to reduce IV medication errors. A smart pump contains built-in software that is programmed with facility-specific dosing profiles. The pump is able to “check” the dose-limits and other clinical guidelines, and when the pump is set up for patient use, it can warn the nurse if a potentially unsafe drug dose or therapy is entered. 489 FIG. 9.63 An electronic smart pump. The two components on the right side are a patientcontrolled analgesia pump. (From Perry, A. G., & Potter, P. A. [2014]. Clinical nursing skills and techniques [8th ed.]. St. Louis, MO: Mosby.) Intravenous Push Medications Always begin by performing hand hygiene and maintain Standard Precautions (see Box 9.1). When administering IV push (or bolus) medications, keep in mind the following points: • Registered nurses are usually the only nursing staff members, besides a nurse anesthetist, allowed to give IV push medications. This may vary at different health care facilities. • IV push injections allow for rapid IV administration of a drug. The term bolus refers to a dose given all at once. IV push injections may be given through an existing IV line, through an IV (saline) lock, or directly into a vein. • Because the medication may have an immediate 490 effect, monitor the patient closely for adverse reactions as well as for therapeutic effects. • Follow the manufacturer's instructions carefully when preparing an IV push medication. Some drugs require careful dilution. Consult a pharmacist if you are unsure about the dilution procedure. Improper dilution may increase the risk for phlebitis and other complications. • Some drugs are never given by IV push. Examples include dopamine, potassium chloride, and antibiotics such as vancomycin. • Small amounts of medication, less than 1 mL, need to be diluted in 5 to 10 mL of NS or another compatible fluid to ensure that the medication does not collect in a “dead space” of the tubing (such as the Y-site port). Check facility policy. • Most drugs given by IV push injection are to be given over a period of 1 to 5 minutes to reduce local or systemic adverse effects. Always time the administration with a watch or clock, because it is difficult to estimate the time accurately. Adenosine, however, must be given very rapidly, within 2 to 3 seconds, for optimal action (see Chapter 25). ALWAYS check packaging information for guidelines, because many errors and adverse effects have been associated with toorapid IV drug administration. Intravenous Push Medications Through an Existing Infusion 491 • Prepare the medication for injection. Check compatibility of the IV medication with the existing IV solution. • Choose the injection port that is closest to the patient. • Remove the cap, if present, and cleanse the injection port with an antiseptic swab vigorously for 15 seconds (Fig. 9.64). FIG. 9.64 Before attaching the syringe for an intravenous push medication, cleanse the port vigorously for 15 seconds. • Occlude the IV line by pinching the tubing just above the injection port. Attach the syringe to the injection port. Gently aspirate for blood return. • While keeping the IV tubing clamped, slowly 492 inject the medication according to facility policy (Fig. 9.65). Be sure to time the injection with a watch or clock. FIG. 9.65 Pinch the tubing just above the injection port when giving an intravenous (IV) push medication through an IV line. • After the injection, release the IV tubing, remove the syringe, and check the infusion rate of the IV fluid. Intravenous Push Medications Through an Intravenous Lock • Obtain two syringes of 0.9% NS, often supplied in prefilled 10-mL syringes. Prepare medication 493 for injection and follow facility policy for IV lock flushes. If ordered, prepare a syringe with heparin flush solution. • Cleanse the injection port of the IV lock vigorously with an antiseptic swab for 15 seconds. • Insert the syringe of NS into the injection port (Fig. 9.66). Open the clamp of the IV lock tubing, if present. FIG. 9.66 Attaching the syringe to the intravenous (IV) lock, using a needleless system, for IV push medication administration. • Gently aspirate and observe for blood return. Absence of blood return does not mean that the IV line is occluded; further assessment may be required. • Flush gently with saline while assessing for resistance. If resistance is felt, do not apply force. 494 Stop and reassess the IV lock. • Observe for signs of infiltration while injecting NS. • Reclamp the tubing (if a clamp is present), and remove the NS syringe. Repeat cleansing of the port, and attach the medication syringe. Open the clamp again. • Inject the medication over the prescribed length of time (Fig. 9.67). Measure time with a watch or clock. FIG. 9.67 Slowly inject the intravenous (IV) push medication through the IV lock; use a watch or clock to time the injection. • When the medication is infused, clamp the IV lock tubing (if a clamp is present) and remove the 495 syringe. • Repeat cleansing of the port; attach an NS syringe and inject the contents into the IV lock slowly. If a heparin flush is ordered, attach the syringe containing heparin flush solution and inject slowly (per facility policy). After Injection of Intravenous Push Medications • Monitor the patient closely for adverse effects. Monitor the IV infusion site for signs of phlebitis and infiltration. • Document medication given on the medication record, and monitor the patient for a therapeutic response as well as for adverse reactions. Topical Drugs Administering Eye Medications Always begin by performing hand hygiene and maintain Standard Precautions (see Box 9.1). Gloves must be worn. When administering eye preparations, keep in mind the following points: • Make sure the patient is not wearing contact lenses. Assist the patient to a supine or sitting position. Tilt the patient's head back slightly. • Remove any secretions with a warm, damp washcloth; be sure to wipe from the inner to outer canthus (Fig. 9.68). 496 FIG. 9.68 Cleanse the eye, washing from the inner to outer canthus, before giving eye medications. • Have the patient tilt his or her head slightly back and look up. With your nondominant hand, gently pull the lower lid open to expose the conjunctival sac. Eye Drops • With your dominant hand resting on the patient's forehead, hold the eye medication dropper 1 to 2 cm above the conjunctival sac. Do not touch the tip of the dropper to the eye or with your fingers (Fig. 9.69). 497 FIG. 9.69 Insert the eye drop into the lower conjunctival sac. • Drop the prescribed number of drops into the conjunctival sac. Never apply eye drops directly onto the cornea. • If the drops land on the outer lid margins (if the patient moved or blinked), repeat the procedure. • Age-related considerations: Infants often squeeze the eyes tightly shut to avoid eye drops. To give drops to an uncooperative infant, restrain the head gently and place the drops at the corner near the nose where the eyelids meet. When the eye opens, the medication will flow into the eye. Eye Ointment • Gently squeeze the tube of medication to apply an even strip of medication (about 1 to 2 cm) along the border of the conjunctival sac. Start at the inner canthus and move toward the outer canthus (Fig. 9.70). 498 FIG. 9.70 Applying eye ointment. Move from the inner to outer canthus, along the border of the conjunctival sac. (From Rick Brady, Riva, MD.) After Instillation of Eye Medications • Ask the patient to close the eye gently. Squeezing the eye shut may force the medication out of the conjunctival sac. A tissue may be used to blot liquid that runs out of the eye, but instruct the patient not to wipe the eye. • You may apply gentle pressure to the patient's nasolacrimal duct for 30 to 60 seconds with a gloved finger wrapped in a tissue. This will help reduce systemic absorption of the drug through the nasolacrimal duct (Fig. 9.71). 499 FIG. 9.71 Applying gentle pressure against the nasolacrimal duct after giving eye medication. (From Rick Brady, Riva, MD.) • If multiple eyedrops are due at the same time, then wait several minutes before administering the second medication. Check the instructions for the specific drug. • Assist the patient to a comfortable position. Warn the patient that vision may be blurry for a few minutes. • Document the medication given on the medication record, and monitor the patient for a therapeutic response as well as for adverse reactions. Administering Eardrops Always begin by performing hand hygiene and maintain Standard Precautions (see Box 9.1). Apply clean gloves if ear drainage is noted. When administering ear preparations, keep in mind the following points: • After explaining the procedure to the patient, 500 assist the patient to a side-lying position with the affected ear facing up. If cerumen or drainage is noted in the outer ear canal, remove it carefully without pushing it back into the ear canal. • Remove excessive amounts of cerumen before instillation of medication. • If refrigerated, warm the ear medication by taking it out of refrigeration for at least 30 minutes before administration. Instillation of cold eardrops can cause nausea, dizziness, and pain. • Age-related considerations: For an adult or a child older than 3 years of age, pull the pinna up and back (Fig. 9.72). For an infant or a child younger than 3 years of age, pull the pinna down and back (Fig. 9.73). FIG. 9.72 For adults, pull the pinna up and back. 501 FIG. 9.73 For infants and children younger than 3 years of age, pull the pinna down and back. • Administer the prescribed number of drops. Hold the dropper 1 cm above the ear canal, and direct the drops along the sides of the ear canal rather than directly onto the eardrum. • Instruct the patient to lie on his or her side for 5 to 10 minutes. Gently massaging the tragus of the ear with a finger will help to distribute the medication down the ear canal. • If ordered, a loose cotton pledget can be gently inserted into the ear canal to prevent the medication from flowing out. The cotton must remain somewhat loose to allow any discharge to drain out of the ear canal. To prevent the dry cotton from absorbing the eardrops that were instilled, moisten the cotton with a small amount of medication before inserting the pledget. Insertion of cotton too deeply may result in increased pressure within the ear canal and on the eardrum. Remove the cotton after about 15 502 minutes. • If medication is needed in the other ear, wait 5 to 10 minutes after instillation of the first eardrops before administering. • Document the medication given on the medication record, and monitor the patient for a therapeutic response as well as for adverse reactions. Administering Inhaled Drugs Always begin by performing hand hygiene and maintain Standard Precautions (see Box 9.1). Gloves may be worn. Patients with asthma need to monitor their peak expiratory flow rates by using a peak flow meter. A variety of inhalers are available (Fig. 9.74). Be sure to check for specific instructions from the manufacturer as needed. Improper use will result in inadequate dosing. See the box Safety and Quality Improvement: Inhaler Errors Lead to Reduced Effectiveness. When administering inhaled preparations, keep in mind the following points: FIG. 9.74 Various metered-dose inhalers. 503 Safety and Quality Improvement: Preventing Medication Errors Inhaler Errors Lead to Reduced Effectiveness The Institute for Safe Medication Practices (ISMP) outlined errors in inhaler self-administration that result in omitted doses, overdoses, and poor outcomes for patients who use inhaler medications. Common errors with inhalers included: • Patients not holding their breath long enough after inhaling a dose • Omitting maintenance inhalers when asymptomatic • Using an empty inhaler while believing it still contained medication • Inhaling at the wrong time instead of when pressing the inhaler • Aiming the inhaler improperly toward the roof of the mouth or the tongue Other errors included: • Failing to load a dose in a dry-powder inhaler (DPI) • Loss of some of the DPI medication by holding the mouthpiece upside-down after loading a dose • Not inhaling strongly enough to draw the DPI medication out of the device It is essential for nurses to ensure that patients understand inhalers. Be sure to assess the patient's self-administration technique and reinforce teaching as needed. For more information, see the ISMP website at www.ismp.org/newsletters/nursing/issues/NurseAdviseERR201609.pdf. (Accessed August 21, 2017.) Metered-Dose Inhalers 504 • Shake the metered-dose inhaler (MDI) gently before using. • Remove the cap and inspect the mouthpiece to ensure that there are no foreign objects in the mouthpiece. Inhalation of a foreign object could cause serious injury. • Hold the inhaler upright and grasp it with the thumb and first two fingers. • Tilt the patient's head back slightly. • If the inhaler is used without a spacer, do the following: 1. Have the patient open his or her mouth; position the inhaler 1 to 2 inches away from the patient's mouth (Fig. 9.75). For self-administration, some patients may measure this distance as 1 to 2 finger widths. This is considered the best way to use the MDI without a spacer. FIG. 9.75 Using a metered-dose inhaler without a spacer. (From Rick Brady, Riva, MD.) 2. Alternatively, the patient may place the inhaler mouthpiece in the mouth with 505 the opening toward the back of the throat (Fig. 9.76). FIG. 9.76 Another method for using a metered-dose inhaler without a spacer. 3. Have the patient exhale completely, and then press down once on the inhaler to release the medication; have the patient breathe in slowly and deeply for 5 seconds. 4. Have the patient hold his or her breath for approximately 10 seconds and then exhale slowly through the nose or pursed lips. • Age-related considerations: Spacers can be used with children and adults who have difficulty coordinating inhalations with activation of MDIs (see Chapter 37). If the inhaler is used with a spacer, do the following: 1. Attach the spacer to the mouthpiece of the inhaler after removing the inhaler cap. 2. Place the mouthpiece of the spacer in the 506 patient's mouth. 3. Have the patient exhale. 4. Press down on the inhaler to release the medication, and have the patient inhale deeply and slowly through the spacer. The patient then needs to breathe in and out slowly for 2 to 3 seconds, and then hold his or her breath for 10 seconds (Fig. 9.77). FIG. 9.77 Using a spacer device with a metered-dose inhaler. • If a second dose of the same medication is ordered, wait 20 to 30 seconds between inhalations. • If a second type of inhaled medication is ordered, wait 2 to 5 minutes between medication inhalations. • If both a bronchodilator and a corticosteroid inhaled medication are ordered, the bronchodilator needs to be administered first so that the passages will be more open for the second medication. • Instruct the patient to replace the cap onto the 507 mouthpiece of the inhaler. • Instruct the patient to rinse his or her mouth with water after inhaling a corticosteroid medication to prevent the development of an oral fungal infection. • Document the medication given on the medication record, and monitor the patient for a therapeutic response as well as for adverse reactions. • It is important to teach the patient to be aware of the number of doses in the inhaler and to keep track of uses. Simply shaking the inhaler to “estimate” whether it is empty is not accurate and may result in its being used when it is empty. Many MDIs now come with devices that help to count the remaining doses. Dry powder inhalers (DPI) have varied instructions, so follow the manufacturer's instructions closely. Instruct patients to cover the mouthpiece completely with their mouths. Capsules that are intended for use with these inhalers must NEVER be taken orally. Most DPIs also have convenient built-in dose counters. Small-Volume Nebulizers • In some health care facilities, the air compressor is located in the wall unit of the room. A small portable air compressor is used at home and in areas where wall units are not available. Be sure to follow the manufacturer's instructions for use. 508 • Nebulizer treatments may be performed by a respiratory therapist or a nurse. Always closely monitor the patient before, during, and after the drug administration. • Be sure to take the patient's baseline heart rate, especially if a beta-adrenergic drug is used. Some drugs may increase the heart rate. • After gathering the equipment, add the prescribed medication to the nebulizer cup (Fig. 9.78). Some medications will require a diluent; others are premixed with a diluent. Be sure to verify before adding a diluent. FIG. 9.78 Adding medication to the nebulizer cup. (From Rick Brady, Riva, MD.) • Have the patient hold the mouthpiece between his or her lips (Fig. 9.79). 509 FIG. 9.79 Administering a small-volume nebulizer treatment. (From Rick Brady, Riva, MD.) • Age-related considerations: Use a face mask for a child or an adult who is too fatigued to hold the mouthpiece. Special adaptors are available if the patient has a tracheostomy. • Before starting the nebulizer treatment, have the patient take a slow, deep breath, hold it briefly, and then exhale slowly. Instruct patients who are short of breath to hold their breath every fourth or fifth breath for 5 to 10 seconds. • Turn on the small-volume nebulizer machine (or turn on the wall unit), and make sure that a sufficient mist is forming. • Instruct the patient to repeat the breathing pattern mentioned previously during the treatment. • Occasionally tap the nebulizer cup during the treatment and toward the end to move the fluid droplets back to the bottom of the cup. • Monitor the patient throughout treatment to 510 ensure that the nebulizer medication is properly administered. • Monitor the patient's heart rate during and after the treatment. • If inhaled steroids are given, instruct the patient to rinse his or her mouth with water afterward. • After the procedure, clean and store the tubing per facility policy. • Document the medication given on the medication record, and monitor the patient for a therapeutic response as well as for adverse reactions. • If the patient will be using a nebulizer at home, instruct the patient to rinse the nebulizer parts after each use with warm, clear water and to airdry. Wash the parts daily with warm, soapy water and allowed to air-dry. Once a week, soak the nebulizer parts in a solution of vinegar and water (four parts water and one part white vinegar) for 30 minutes; rinse thoroughly with clear, warm water; and air-dry. Storing nebulizer parts that are still wet will encourage bacterial and mold growth. Administering Medications to the Skin Always begin by performing hand hygiene and maintain Standard Precautions (see Box 9.1). Gloves must be worn; sterile gloves are used if applying topical medications to open skin lesions. Avoid touching the preparations to your own skin. When administering skin preparations, keep in mind the following points: Lotions, Creams, Ointments, and Powders 511 • Apply powder to clean, dry skin. Have the patient turn his or her head to the other side during application to avoid inhalation of powder particles. • Apply lotion to clean, dry skin. Remove residual from previous applications with soap and water. • Before administering any dose of a topical skin medication, ensure that the site is dry and free of irritation. Thoroughly remove previous applications using soap and water, if appropriate for the patient's condition, and dry the area thoroughly. Be sure to remove any debris, drainage, or pus if present. • Age-related considerations: The skin of an older patient may be more fragile and easily bruised. Be sure to handle the skin gently when cleansing to prepare the site for medication and when applying medications. • With lotion, cream, or gel, obtain the correct amount with your gloved hand (Fig. 9.80). If the medication is in a jar, remove the dose with a sterile tongue depressor and apply to your gloved hand. Do not contaminate the medication in the jar. 512 FIG. 9.80 Use gloves to apply topical skin preparations. (From Rick Brady, Riva, MD.) • Apply the preparation with long, smooth, gentle strokes that follow the direction of hair growth (Fig. 9.81). Avoid excessive pressure. Be especially careful with the skin of older adults, because agerelated changes may result in increased capillary fragility and tendency to bruise. FIG. 9.81 Spread the lotion on the skin with long, smooth, gentle strokes. (From Rick Brady, Riva, MD.) 513 • Some ointments and creams may soil the patient's clothes and linens. If ordered, cover the affected area with gauze or a transparent dressing. • Nitroglycerin ointment in a tube is measured carefully on clean ruled application paper before it is applied to the skin (Fig. 9.82). Unit-dose packages are not measured. Always remove the old medication before applying a new dose. Do not massage nitroglycerin ointment into the skin. Apply the measured amount onto a clean, dry site, and then secure the application paper with a transparent dressing or a strip of tape. Rotate application sites. FIG. 9.82 Measure nitroglycerin ointment carefully before application. (From Rick Brady, Riva, MD.) Transdermal Patches • Be sure that the old patch is removed as ordered. Some patches may be removed before the next patch is due, so check the order. Clear patches may be difficult to find, and patches may be 514 overlooked in obese patients with skinfolds. Cleanse the site of the old patch thoroughly. Observe for signs of skin irritation at the old patch site. Rotate sites of application with each dose. • Transdermal patches need to be applied at the same time each day if ordered daily. • The old patch can be pressed together and then wrapped in a glove as you remove the glove from your hand. Dispose of it in the proper container according to facility policy. • Select a new site for application and ensure that it is clean and without powder or lotion. For best absorption and fewest adverse effects, the site needs to be hairless and free from scratches or irritation. If it is necessary to remove hair, clip the hair instead of shaving to reduce irritation to the skin. Application sites may vary. Follow the drug manufacturer's specific instructions as to where to apply the patch. • Remove the backing from the new patch (Fig. 9.83). Take care not to touch the medication side of the patch with your fingers. 515 FIG. 9.83 Opening a transdermal patch medication. (From Rick Brady, Riva, MD.) • Place the patch on the skin site, and press firmly (Fig. 9.84). Press around the edges of the patch with one or two fingers to ensure that the patch is adequately secured to the skin. Hold the palm of one hand over the patch for 10 seconds and make sure it adheres well. If an overlay is provided by the drug manufacturer, apply it over the patch. FIG. 9.84 Ensure that the edges of the transdermal patch are secure after applying. (From Rick Brady, Riva, MD.) 516 • Instruct the patient not to cut transdermal patches. Cutting transdermal patches releases all of the medication at once and may result in a dangerous overdose. After Administration of Topical Skin Preparations • Document the medication given on the medication record, and monitor the patient for a therapeutic response as well as for adverse reactions. • Provide instruction on administration to the patient and/or caregiver. Administering Nasal Medications Always begin by performing hand hygiene and maintain Standard Precautions (see Box 9.1). Patients may self-administer some of these drugs after proper instruction. Gloves must be worn. When administering nasal medications, keep in mind the following points: • Before giving nasal medications, explain the procedure to the patient and tell him or her that temporary burning or stinging may occur. Instruct the patient that it is important to clear the nasal passages by blowing his or her nose, unless contraindicated (e.g., with increased intracranial pressure or nasal surgery), before administering the medication. Assess for deviated septum or a history of nasal fractures, because these may impede the patient's ability to inhale through the 517 affected nostril. • Fig. 9.85 illustrates various delivery forms for nasal medications: sprays, drops, and metereddose sprays. FIG. 9.85 Nasal medications may come in various delivery forms. • Assist the patient to a supine position. Support the patient's head as needed. • If specific areas are targeted for the medication, position as follows: • For the posterior pharynx, position the head backward. • For the ethmoid or sphenoid sinuses, place the head gently over the top edge of the bed, or place a pillow under the shoulders and tilt the head back. • For the frontal or maxillary sinuses, place the head back and turned toward the side that is to receive the medication. Nasal Drops 518 • Hold the nose dropper approximately inch above the nostril. Administer the prescribed number of drops toward the midline of the ethmoid bone (Fig. 9.86). FIG. 9.86 Administering nose drops. • Repeat the procedure as ordered, instilling the indicated number of drops per nostril. • Keep the patient in a supine position for 5 minutes. • Age-related considerations: Infants are nose breathers, and the potential congestion caused by nasal medications may make it difficult for them to suck. If nose drops are ordered, administer the drops 20 to 30 minutes before a feeding. Nasal Spray • While the patient is sitting upright, occlude one nostril by pressing a finger against the outer nare. After gently shaking the nasal spray container, insert the tip into the other nostril. Point the spray tip toward the side of the nose, not toward the center of the nose. Squeeze the spray bottle into 519 the nostril while the patient inhales (Fig. 9.87). FIG. 9.87 Before self-administering the nasal spray, the patient needs to occlude the other nostril. • Repeat the procedure as ordered, instilling the indicated number of sprays per nostril. After Administration of Nasal Medicines • Offer the patient tissues for blotting any drainage, but instruct the patient to avoid blowing his or her nose for several minutes after instillation of the drops. • Assist the patient to a comfortable position. • Document the medication given on the medication record, and document drainage, if any. Monitor the patient for a therapeutic response as well as for adverse reactions. Administering Vaginal Medications 520 Always begin by performing hand hygiene and maintain Standard Precautions (see Box 9.1). Gloves must be worn. When administering vaginal preparations, keep in mind the following points: • Vaginal suppositories are larger and more oval than rectal suppositories (Fig. 9.88). FIG. 9.88 Vaginal suppositories (right) are larger and more oval than rectal suppositories (left). (From Rick Brady, Riva, MD.) • Fig. 9.89 shows examples of a vaginal suppository in an applicator and vaginal cream in an applicator. FIG. 9.89 Vaginal cream and suppository, with applicators. (From Rick Brady, Riva, MD.) • Before giving these medications, explain the 521 procedure to the patient and have her void to empty her bladder. • If possible, administer vaginal preparations at bedtime to allow the medications to remain in place as long as possible. • Some patients may prefer to self-administer vaginal medications. Provide specific instructions if necessary. • Position the patient in the lithotomy position and elevate the hips with a pillow, if tolerated. Be sure to drape the patient to provide privacy. Creams, Foams, or Gels Applied With an Applicator • Fit the applicator to the tube of the medication, and then gently squeeze the tube to fill the applicator with the correct amount of medication. • Lubricate the tip of the applicator with a watersoluble lubricant. • Use your nondominant hand to spread the labia and expose the vagina. Gently insert the applicator approximately 2 to 3 inches (Fig. 9.90). 522 FIG. 9.90 Administering vaginal cream with an applicator. (From Elkin, M. K., Perry, A. G., & Potter, P. A. [2004]. Nursing interventions and clinical skills [3rd ed.]. St. Louis, MO: Mosby.) • Push the plunger to deposit the medication. Remove the applicator and wrap it in a paper towel for cleaning. Wash the applicator with soap and water, and store in a clean container for the next use. Suppositories or Vaginal Tablets • For suppositories or vaginal tablets, remove the wrapping and lubricate the suppository with a water-soluble lubricant. Be sure that the suppository is at room temperature. • Using the applicator provided, insert the suppository or tablet into the vagina, and then 523 push the plunger to deposit the suppository. Remove the applicator. • If no applicator is available, use your dominant index finger to insert the suppository about 3 to 4 inches into the vagina (Fig. 9.91). FIG. 9.91 Administering a vaginal suppository. (From Elkin, M. K., Perry, A. G., & Potter, P. A. [2004]. Nursing interventions and clinical skills [3rd ed.) St. Louis, MO: Mosby.) • Have the patient remain in a supine position with hips elevated for 5 to 10 minutes to allow the suppository to melt and the medication to be absorbed. • If the patient desires, apply a perineal pad. • If the applicator is to be reused, wash it with soap and water, and store in a clean container for 524 the next use. • Document the medication given on the medication record, and monitor the patient for a therapeutic response as well as for adverse reactions. References Barrons R, Pegram A, Borries A. Inhaler device selection: Special considerations in elderly patients with chronic obstructive pulmonary disease. American Journal of Health-System Pharmacy. 2011;68(13):1221–1232. Bradshaw E, Collins B, Williams J. Administering rectal suppositories: preparation, assessment and insertion. Gastrointestinal Nursing. 2009;7(9):24–28. Cohen H. Preventing adverse drug events from topical medications. Nursing. 2013;43(7):68–69. Dobbins EH. Sidestep the perils of PCA in post-op patients. Nursing. 2015;45(4):64–69. Dulan A, Sheridan D, Laucher MA. Using transdermal patches for older adults. Nursing. 2016;46(11):69. Guenter P, Boullata J. Drug administration by enteral feeding tubes. Nursing. 2013;43(12):26–33. Hockenberry MJ, Wilson D. Wong's nursing care of infants and children. 10th ed. Mosby: St Louis, MO; 2015. Institute for Safe Medication Practices. Correct use of inhalers: help patients breathe easier. Nurse Advise ERR. 2016;14(9) [Available at] http://www.ismp.org/newsletters/nursing/issues/NurseAdvi Institute for Safe Medication Practices. Hazard alert! 525 Asphyxiation possible with syringe tip caps. ISMP Medication Safety Alert!. 2001 [Available at] www.ismp.org/hazardalerts/Hypodermic.asp. Institute for Safe Medication Practices. How fast is too fast for IV push medication?. 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ISMP Medication Safety Alert!. 2007 [Available at] www.ismp.org/Newsletters/acutecare/articles/20070419.asp Lindauer A, Sexson K, Harvath TA. Teaching caregivers to administer eye drops, transdermal patches, and suppositories. American Journal of Nursing. 2017;117(1):54–59. Miller D, Miller H. To crush or not to crush? Nursing. 2000;30(2):50–52. Moureau NL, Dawson RB. Keeping needleless 526 connectors clean, part 1. Nursing. 2010;40(5):18–19. Moureau NL, Dawson RB. Keeping needleless connectors clean, part 2. Nursing. 2010;40(6):61–63. Perry AG, Potter PA, Ostendorf WR. Clinical nursing skills & techniques. 9th ed. Mosby: St Louis, MO; 2018. Pruitt W. Teaching your patient to use a peak flowmeter. Nursing. 2005;35(3):54–55. Pullen R. Clinical do's and don'ts: administering medication by the Z-track method. Nursing. 2005;35(7):24. Pullen R. Clinical do's and don'ts: administering an orally disintegrating tablet. Nursing. 2008;38(1):18. Sexson K, Lindauer A, Harvath T. Administration of subcutaneous injections. American Journal of Nursing. 2017;117(5):S7–S10. Shastay AD. Evidence-based safe practice guidelines for I.V. push medications. Nursing. 2016;46(10):38– 44. Walsh L, Brophy K. Most nurses don't follow guidelines on IM injections. Journal of Advanced Nursing. 2011;67(5):1034–1040. Yildiz F. Importance of inhaler device use status in the control of asthma in adults: the asthma inhaler treatment study. Respiratory Care. 2014;59(2):223– 230. 527 PA R T 2 Drugs Affecting the Central Nervous System OUTLINE 10 Analgesic Drugs 11 General and Local Anesthetics 12 Central Nervous System Depressants and Muscle Relaxants 13 Central Nervous System Stimulants and Related Drugs 14 Antiepileptic Drugs 15 Antiparkinson Drugs 16 Psychotherapeutic Drugs 17 Substance Use Disorder 528 10 Analgesic Drugs OBJECTIVES When you reach the end of this chapter, you will be able to do the following: 1. Define acute pain and chronic pain. 2. Contrast the signs, symptoms, and management of acute and chronic pain. 3. Discuss the pathophysiology and characteristics associated with cancer pain and other special pain situations. 4. Describe pharmacologic and nonpharmacologic approaches for the management of acute and chronic pain. 5. Discuss the use of nonopioids, nonsteroidal antiinflammatory drugs, opioids (opioid agonists, opioids with mixed actions, opioid agonistsantagonists and antagonists), and miscellaneous drugs in the management of pain, including acute and chronic pain, cancer pain, and special pain situations. 6. Identify examples of drugs classified as nonopioids, nonsteroidal antiinflammatory drugs, opioids (opioid agonists, opioids with mixed actions, opioid agonists-antagonists and antagonists), and miscellaneous drugs. 7. Briefly describe the mechanism of action, indications, dosages, routes of administration, adverse effects, toxicity, cautions, contraindications, and drug interactions of nonopioids, nonsteroidal 529 antiinflammatory drugs (see Chapter 44), opioids (opioid agonists, opioids with mixed actions, opioid agonists-antagonists and antagonists), and miscellaneous drugs. 8. Contrast the pharmacologic and nonpharmacologic management of acute and chronic pain with the management of pain associated with cancer and pain experienced in terminal conditions. 9. Briefly describe the specific standards of pain management as defined by the World Health Organization and The Joint Commission. 10. Develop a nursing care plan based on the nursing process related to the use of nonopioid and opioid drug therapy for patients in pain. 11. Identify various resources, agencies, and professional groups that are involved in establishing standards for the management of all types of pain and for promotion of a holistic approach to the care of patients with acute or chronic pain and those in special pain situations. KEY TERMS Acute pain Pain that is sudden in onset, usually subsides when treated, and typically occurs over less than a 6-week period. Addiction A chronic, neurobiologic disease whose development is influenced by genetic, psychosocial, and environmental factors (same as psychologic dependence). Adjuvant analgesic drugs Drugs that are added for combined therapy with a primary drug and may have additive or independent analgesic properties, or both. Agonist A substance that binds to a receptor and causes a response. Agonists-antagonists Substances that bind to a receptor and cause a partial response that is not as strong as that caused by an agonist (also known as a partial agonist). 530 Analgesic ceiling effect Occurs when a given pain drug no longer effectively controls pain despite the administration of the highest safe dosages. Analgesics Medications that relieve pain without causing loss of consciousness (sometimes referred to as painkillers). Antagonist A drug that binds to a receptor and prevents (blocks) a response. Breakthrough pain Pain that occurs between doses of pain medication. Cancer pain Pain resulting from any of a variety of causes related to cancer and/or the metastasis of cancer. Central pain Pain resulting from any disorder that causes central nervous system damage. Chronic pain Persistent or recurring pain that is often difficult to treat. Includes any pain lasting longer than 3 to 6 months, pain lasting longer than 1 month after healing of an acute injury, or pain that accompanies a nonhealing tissue injury. Deep pain Pain that occurs in tissues below skin level; opposite of superficial pain. Gate theory The most well-described theory of pain transmission and pain relief. It uses a gate model to explain how impulses from damaged tissues are sensed in the brain. Narcotics A legal term that originally applied to drugs that produce insensibility or stupor, especially the opioids (e.g., morphine, heroin). Currently used to refer to any medically used controlled substance and to refer to any illicit or “street” drug. (Note: This term is falling out of use in favor of opioid.) Neuropathic pain Pain that results from a disturbance of function in a nerve. Nociception Processing of pain signals in the brain that gives rise to the feeling of pain. Nociceptors A subclass of sensory nerves (A and C fibers) that 531 transmit pain signals to the central nervous system from other body parts. Nonopioid analgesics Analgesics that are not classified as opioids. Nonsteroidal antiinflammatory drugs (NSAIDs) A large, chemically diverse group of drugs that are analgesics and also possess antiinflammatory and antipyretic activity. Opioid analgesics Synthetic drugs that bind to opiate receptors to relieve pain. Opioid naive Describes patients who are receiving opioid analgesics for the first time and who therefore are not accustomed to their effects. Opioid tolerance A normal physiologic condition that results from long-term opioid use, in which larger doses of opioids are required to maintain the same level of analgesia and in which abrupt discontinuation of the drug results in withdrawal symptoms (same as physical dependence). Opioid tolerant The opposite of opioid naïve; describes patients who have been receiving opioid analgesics (legally or otherwise) for a period of time (1 week or longer). Opioid withdrawal The signs and symptoms associated with abstinence from or withdrawal of an opioid analgesic when the body has become physically dependent on the substance. Opioids A class of drugs used to treat pain. This term is often used interchangeably with the term narcotic. Pain An unpleasant sensory and emotional experience associated with actual or potential tissue damage. Pain threshold The level of a stimulus that results in the sensation of pain. Pain tolerance The amount of pain a patient can endure without its interfering with normal function. Partial agonist A drug that binds to a receptor and causes a response that is less than that caused by a full agonist (same as 532 agonist-antagonist). Phantom pain Pain experienced in the area of a body part that has been surgically or traumatically removed. Physical dependence A condition in which a patient takes a drug over a period of time and unpleasant physical symptoms (withdrawal symptoms) occur if the drug is stopped abruptly or smaller doses are given. The physical adaptation of the body to the presence of an opioid or other addictive substance. Psychologic dependence A pattern of compulsive use of opioids or any other addictive substance characterized by a continuous craving for the substance and the need to use it for effects other than pain relief (also called addiction). Referred pain Pain occurring in an area away from the organ of origin. Somatic pain Pain that originates from skeletal muscles, ligaments, or joints. Special pain situations The general term for pain control situations that are complex and whose treatment typically involves multiple medications, and nonpharmacologic therapeutic modalities (e.g., massage, chiropractic care, surgery). Superficial pain Pain that originates from the skin or mucous membranes; opposite of deep pain. Synergistic effects Drug interactions in which the effect of a combination of two or more drugs with similar actions is greater than the sum of the individual effects of the same drugs given alone. For example, 1 + 1 is greater than 2. Tolerance The general term for a state in which repetitive exposure to a given drug, over time, induces changes in drug receptors that reduce the drug's effects (same as physical dependence). Vascular pain Pain that results from pathology of the vascular or perivascular tissues. Visceral pain Pain that originates from organs or smooth muscles. 533 World Health Organization (WHO) An international body of health care professionals that studies and responds to health needs and trends worldwide. Drug Profiles acetaminophen, p. 152 codeine sulfate, p. 148 fentanyl, p. 148 hydromorphone, p. 149 lidocaine, transdermal, p. 152 meperidine hydrochloride, p. 149 methadone hydrochloride, p. 149 morphine sulfate, p. 149 naloxone hydrochloride, p. 150 oxycodone hydrochloride, p. 150 tramadol hydrochloride, p. 152 High-Alert Drugs codeine sulfate, p. 148 fentanyl, p. 148 hydromorphone, p. 149 meperidine hydrochloride, p. 149 methadone hydrochloride, p. 149 morphine sulfate, p. 149 oxycodone hydrochloride, p. 150 tramadol hydrochloride, p. 152 Overview The management of pain is a very important aspect of nursing care. Pain is one of the most common reasons that patients seek health care. Surgical and diagnostic procedures often require pain 534 management, as do several diseases including arthritis, diabetes, multiple sclerosis, cancer, and acquired immunodeficiency syndrome (AIDS). Pain leads to much suffering and is a tremendous economic burden in terms of lost workplace productivity, workers’ compensation payments, and other related health care costs. To provide quality patient care, the nurse must be well informed about both pharmacologic and nonpharmacologic methods of pain management. This chapter focuses on pharmacologic methods of pain management. Nonpharmacologic methods are listed in Box 10.1. Box 10.1 Nonpharmacologic Treatment Options for Pain • Acupressure • Acupuncture • Art therapy • Behavioral therapy • Biofeedback • Comfort measures • Counseling • Distraction • Hot or cold packs • Hypnosis • Imagery • Massage • Meditation • Music therapy • Pet therapy • Physical therapy • Reduction of fear 535 • Relaxation • Surgery • Therapeutic baths • Therapeutic communication • Therapeutic touch • Transcutaneous electric nerve stimulation • Yoga Medications that relieve pain without causing loss of consciousness are classified as analgesics. There are various classes of analgesics, determined by their chemical structures and mechanisms of action. This chapter focuses primarily on the opioid analgesics, which are used to manage moderate to severe pain. Often drugs from other chemical categories are added to the opioid regimen as adjuvant analgesic drugs (or adjuvants) and are described later. Pain is most commonly defined as an unpleasant sensory and emotional experience associated with either actual or potential tissue damage. It is a very personal and individual experience. Pain can be defined as whatever the patient says it is, and it exists whenever the patient says it does. Although the mechanisms of pain are becoming better understood, a patient's perception of pain is a complex process. Pain involves physical, psychologic, and even cultural factors (see the box “Patient-Centered Care: Cultural Implications”). Because pain intensity cannot be precisely quantified, health care providers must cultivate relationships of mutual trust with their patients to provide optimal care. Patient-Centered Care: Cultural Implications The Patient Experiencing Pain • Each culture has its own beliefs, thoughts, and ways of approaching, defining, and managing pain. Attitudes, 536 meanings, and perceptions of pain vary with culture, race, and ethnicity. • African Americans believe in the power of healers who rely strongly on the religious faith of people and often use prayer and the laying on of hands for relief of pain. • Hispanic Americans believe in prayer, the wearing of amulets, and the use of herbs and spices to maintain health and wellness. Specific herbs are used in teas and therapies, often including religious practices, massage, and cleansings. • Some traditional methods of healing for the Chinese include acupuncture, herbal remedies, yin and yang balancing, and cold treatment. Moxibustion, in which cones or cylinders of pulverized wormwood are burned on or near the skin over specific meridian points, is another form of healing. • Asian and Pacific Islander patients are often reluctant to express their pain because they believe that the pain is God's will or is punishment for past sins. • For many Native Americans, treatments for pain include massage, the application of heat, sweat baths, herbal remedies, and being in harmony with nature. • In Arab culture, patients are expected to express their pain openly and anticipate immediate relief, preferably through injections or intravenous drugs. • Remain aware of all cultural influences on health-related behaviors and on patients’ attitudes toward medication therapy and thus, ultimately, on its effectiveness. A thorough assessment that includes questions about the patient's cultural background and practices is important to the effective and individualized delivery of nursing care. There is no single approach to effective pain management. Instead, pain management is tailored to each patient's needs. The cause of the pain, the existence of concurrent medical conditions; the characteristics of the pain; and the psychological and cultural characteristics of the patient need to be considered. Adequate pain management also requires ongoing reassessment of the pain and the effectiveness of treatment. The patient's emotional response to 537 pain depends on his or her psychologic experiences of pain. Pain results from the stimulation of sensory nerve fibers known as nociceptors. These receptors transmit pain signals from various body regions to the spinal cord and brain, which leads to the sensation of pain, or nociception (Fig. 10.1). FIG. 10.1 Illustration of the four processes of nociception. (From Jarvis, C. [2016]. Physical examination and health assessment [7th ed.]. St Louis: Saunders.) The physical impulses that signal pain activate various nerve pathways from the periphery to the spinal cord and to the brain. The level of stimulus needed to produce a painful sensation is referred to as the pain threshold. Because this is a measure of the physiologic response of the nervous system, it is similar for most individuals. However, variations in pain sensitivity may result from genetic factors. There are three main receptors believed to be involved in pain. 538 The mu receptors in the dorsal horn of the spinal cord appear to play the most crucial role. Less important but still involved in pain sensations are the kappa and delta receptors. Pain receptors are located in both the central nervous system (CNS) and various body tissues. Pain perception is closely linked to the number of mu receptors. This number is controlled by a single gene, the mu opioid receptor gene. When the number of receptors is high, pain sensitivity is diminished. Conversely, when the receptors are reduced or missing altogether, relatively minor noxious stimuli may be perceived as painful. The patient's emotional response to the pain is also molded by the patient's age, sex, culture, previous pain experience, and anxiety level. Whereas pain threshold is the physiologic element of pain, the psychologic element of pain is called pain tolerance. This is the amount of pain a patient can endure without its interfering with normal function. Because it is a subjective response, pain tolerance can vary from patient to patient. Pain tolerance can be modulated by the patient's personality, attitude, environment, culture, and ethnic background. Pain tolerance can even vary within the same person depending on the circumstances involved. Table 10.1 lists the various conditions that can alter one's pain tolerance. TABLE 10.1 Conditions That Alter Pain Tolerance Pain Conditions Threshold Lowered Anger, anxiety, depression, discomfort, fear, isolation, chronic pain, sleeplessness, tiredness Raised Diversion, empathy, rest, sympathy, medications (analgesics, antianxiety drugs, antidepressants) Pain can also be further classified in terms of its onset and duration as either acute or chronic. Acute pain is sudden and usually subsides when treated. One example of acute pain is postoperative pain. Chronic pain is persistent or recurring, lasting 3 to 6 months. It is often more difficult to treat, because changes occur in the nervous system that often require increasing drug dosages. This situation is known by the general term tolerance or physical dependence (see Chapter 17). Acute pain and chronic pain differ in 539 their onset and duration, their associated diseases or conditions, and the way they are treated. Table 10.2 lists the different characteristics of acute and chronic pain and various diseases and conditions associated with each. TABLE 10.2 Acute Versus Chronic Pain Type Onset of Pain Acute Sudden (minutes to hours); usually sharp, localized; physiologic response (SNS: tachycardia, sweating, pallor, increased blood pressure) Duration Examples Limited (has an end) Myocardial infarction, appendicitis, dental procedures, kidney stones, surgical procedures Chronic Slow (days to months); long duration; Persistent Arthritis, cancer, lower dull, persistent aching or back pain, peripheral recurring neuropathy (endless) SNS, Sympathetic nervous system. Pain can be further classified according to its source. The two most common sources of pain are somatic and visceral. Somatic pain originates from skeletal muscles, ligaments, and joints. Visceral pain originates from organs and smooth muscles. Superficial pain originates from the skin and mucous membranes. Deep pain occurs in tissues below skin level. Pain may be appropriately treated when the source of the pain is known. For example, visceral and superficial pain usually require opioids for relief, whereas somatic pain (including bone pain) usually responds better to nonopioid analgesics such as nonsteroidal antiinflammatory drugs (NSAIDs) (see Chapter 44). Pain may be further subclassified according to the diseases or other conditions that cause it. Vascular pain is believed to originate from the vascular or perivascular tissues and is thought to account for a large percentage of migraine headaches. Referred pain occurs when visceral nerve fibers synapse at a level in the spinal cord close to fibers that supply specific subcutaneous tissues in the body. An example is the pain associated with cholecystitis, which is often referred to the back and scapular areas. Neuropathic pain usually 540 results from damage to peripheral or CNS nerve fibers by disease or injury but may also be idiopathic (unexplained). Phantom pain occurs in the area of a body part that has been removed—surgically or traumatically—and is often described as burning, itching, tingling, or stabbing. It can also occur in paralyzed limbs following spinal cord injury. Cancer pain can be acute or chronic or both. It most often results from pressure of the tumor mass against nerves, organs, or tissues. Other causes of cancer pain include hypoxia from blockage of blood supply to an organ, metastases, pathologic fractures, muscle spasms, and adverse effects of radiation, surgery, and chemotherapy. Central pain occurs with tumors, trauma, inflammation, or disease (e.g., cancer, diabetes, stroke, multiple sclerosis) affecting CNS tissues. Several theories attempt to explain pain transmission and pain relief. The most common and well described is the gate theory. This theory, proposed by Melzack and Wall in 1965, uses the analogy of a gate to describe how impulses from damaged tissues are sensed in the brain. First, the tissue injury causes the release of several substances from injured cells, such as bradykinin, histamine, potassium, prostaglandins, and serotonin. Some current pain medications work by altering the actions and levels of these substances (e.g., NSAIDs → prostaglandins; antidepressants → serotonin). The release of these pain-mediating chemicals initiates action potentials (electrical nerve impulses) at the distal end of sensory nerve fibers through pain receptors known as nociceptors. These nerve impulses are conducted along sensory nerve fibers and activate pain receptors in the dorsal horn of the spinal cord. It is here that the so-called gates are located. These gates regulate the flow of sensory nerve impulses. If impulses are stopped by a gate at this junction, no impulses are transmitted to the higher centers of the brain. Conversely, if the gates permit a sufficient number and intensity of action potentials to be conducted from the spinal cord to the cerebral cortex, the sensation of pain is then felt. This is known as nociception. Fig. 10.2 depicts the gate theory of pain transmission. 541 FIG. 10.2 Gate theory of pain transmission. CNS, Central nervous system. Both the opening and the closing of this gate are influenced by the activation of large-diameter A fibers and small-diameter C fibers (Table 10.3). Closing of the gate is affected by the activation of A fibers. This causes the inhibition of impulse transmission to the brain and avoidance of pain sensation. Opening of the gate is affected by the stimulation of C fibers. This allows impulses to be transmitted to the brain and pain to be sensed. The gate is innervated by nerve fibers that originate in the brain and modulate the pain sensation by sending impulses to the gate in the spinal cord. These nerve fibers enable the brain to evaluate, identify, and localize the pain. Thus the brain can control the gate, either keeping the gate closed or allowing it to open so that the brain is stimulated and pain is sensed. The cells that control the gate have a threshold. 542 Impulses that reach these cells must rise above this threshold before an impulse is permitted to travel up to the brain. TABLE 10.3 A and C Nerve Fibers Type of Fiber A Myelin Sheath Yes Fiber Size Large Conduction Speed Fast C No Small Slow Type of Pain Sharp and well localized Dull and non-localized The body is also equipped with certain endogenous neurotransmitters known as enkephalins and endorphins. These substances are produced within the body to fight pain and are considered the body's painkillers. Both are capable of bonding with opioid receptors and inhibiting the transmission of pain impulses by closing the spinal cord gates, in a manner similar to that of opioid analgesic drugs. The term endorphin is a condensed version of the term endogenous morphine. These endogenous analgesic substances are released whenever the body experiences pain or prolonged exertion. They are responsible for the phenomenon of “runner's high.” Fig. 10.1 depicts this entire process. Another phenomenon of pain relief that may be explained by the gate theory is the fact that massaging a painful area often reduces the pain. When an area is rubbed or liniment is applied, large sensory A nerve fibers from peripheral receptors carry painmodulating impulses to the spinal cord. Remember, the A fibers tend to close the gate, which reduces pain sensation in the brain. Treatment of Pain in Special Situations It is estimated that one of every three Americans experiences ongoing pain. Pain is poorly understood and often undertreated. Patient-controlled analgesia (PCA) is commonly used in the hospital setting. In this situation, patients are able to self-medicate by pressing a button on a PCA infusion pump. This has been shown 543 to be very effective and reduces the total opioid dose used. Morphine and hydromorphone are commonly given by PCA. Potential hazards of PCA include well-meaning family members’ pressing the dosing button rather than letting able patients do so on their own. Numerous deaths have occurred when well-meaning family members have administered too much of the opioid drug. This is called PCA by proxy. The Institute for Safe Medication Practices (ISMP) advises against PCA by proxy. For patients who are unable to self-medicate using the PCA pump, a different method of pain control must be used. Patients with complex pain syndromes often benefit from a holistic or multimodal clinical approach that involves pharmacologic and/or nonpharmacologic treatment. Effective drug therapy may include use of opioid and/or nonopioid drugs. The main consideration in pain management for pain associated with cancer is patient comfort and not trying to prevent drug addiction (or psychologic dependence; see Chapter 17). Opioid tolerance is a state of adaptation in which exposure to a drug causes changes in drug receptors that result in reduced drug effects over time. This can occur in as little as 1 week. Because of increasing pathology (e.g., tumor burden), cancer patients usually require increasingly higher opioid doses and thus do become physically dependent on the drugs. Cancer patients are likely to experience withdrawal symptoms if opioid doses are abruptly reduced or discontinued; however, actual psychologic dependence or addiction in such patients is unusual. For long-term pain control, oral, intravenous, subcutaneous, transdermal, and rectal dosing routes are favored over multiple intramuscular injections. The treatment of acute pain in patients who are addicted to opioids is of great concern to health care professionals, who may be reluctant to prescribe opioid therapy. However, habitual street opioid users or patients with chronic pain are opioid tolerant and generally require high dosages. Effective management of acute-onchronic pain requires patients to receive equivalent amounts of their chronic pain medication in addition to an extra 20% to 40% more opioids to treat the acute pain. Longer-acting opioids such as extended-release oxycodone are usually better choices than shorteracting immediate-release drug products for these patients. This is 544 because the shorter-acting drugs are more likely to produce a psychologic “high” or euphoria, which only reinforces addictive tendencies. Genetic differences in cytochrome P-450 enzymes (see Chapters 2 and 8) can cause different patients, whether addicted or not, to respond more or less effectively to a given drug. For this reason, patients must not automatically be viewed with suspicion if they complain that a given drug does not work for them. The label of “addict” can be used unfairly to justify refusal to prescribe pain medications, resulting in undertreatment of pain, even in patients who do not use street drugs. This is now regarded as an inappropriate and inhumane clinical practice. In these situations, control of the patient's pain takes ethical and clinical priority over concerns regarding drug addiction. Nonetheless, prescribers must contend with the reality of abuse of street and/or prescription drugs by patients without genuine pain conditions (see Chapter 17). Such patients often request excessive numbers of prescriptions and may use multiple prescribers and/or pharmacies. Evidence-Based Practice Baccalaureate Nursing Students’ and Faculty's Knowledge and Attitudes Toward Pain Management Review Pain impacts approximately 76 million adults within the United States, and although it is a top priority in care and considered to be the fifth vital sign, pain continues to be inadequately addressed. It is a well-known fact that nurses spend more time with patients than any other health care professional and, as such, nurses are very aware of the patient's needs. One of the main priorities in nursing and health care is that of managing pain. Nurses need to be adequately prepared both in knowledge and clinical skills to assess, plan, implement, and evaluate the pain patients experience regardless of age and cultural diversity. Therefore nurse educators/faculty members must offer didactic, clinical, and evidence-based knowledge about the complex issue of pain. The 545 purpose of this research study was to examine the knowledge and attitudes that junior- and senior-level baccalaureate nursing students and their faculty members held about the management of pain toward patients in pain and to establish a systematic, comprehensive integration of pain in patients who were hospitalized. Methodology This study was conducted at a university in Texas and utilized a convenience sample of both students and faculty. Participants were asked to complete a 36-item Knowledge and Attitudes Survey Regarding Pain (KASRP). This tool consists of two case studies, and respondents are asked to evaluate and manage the pain of the patients described (in the case study). Calculated scores were done as a percentage of correct responses with a minimum score of 80 out of 100%, which was required to earn a satisfactory rating. Findings The final sample included 162 nursing students and 16 faculty members. The two case studies presented were identical in their pain complaints, but the first was described as grimacing and quiet and the second as smiling and conversing on the phone. 83% of the sample was white, female (87%), and younger than 30 years of age (81%). The scores on the KASRP varied from 28% to 86%. Statistically significant differences were found between the scores of the junior- and senior-level nursing students but not between the senior-level students and faculty (at 68% and 71%, respectively). Both scored in the unsatisfactory range. The survey items most frequently yet incorrectly answered were about pain medications. Those questions that were most frequently answered correctly were those about the assessment of pain. More specific information about the case studies includes the following: faculty accurately assessed pain in the second scenario as compared to the students; the students most accurately assessing pain in the second scenario were first-semester junior students (86%), whereas only 59.4% of second-semester students and 77% of first-semester senior nursing students made the correct assessment. In all cases, the nursing students who answered incorrectly were assessing the pain at a lower level than that of the patient's own pain assessment. 546 Interestingly enough, students correctly assessing pain often chose incorrect pain management strategies with less than optimal doses of pain medication. In a few situations, no pain medication was selected at all. The findings of this research study must be interpreted with caution due to limitations, such as a small sample size and use of only a single academic institution. However, the findings are still significant and can assist in the care of patients with pain. Significant findings of this study (and consistent with other studies) offering us areas of direction for further education include the finding that knowledge deficits were found in the area of pain medications. Scores associated with pain assessment were found to be higher, as with other studies. Even if the student or faculty correctly assessed the patient's pain level, the selection of intervention was often incorrect. Application to Nursing Practice The results of this study emphasize the fact that more needs to be done in regard to the adequate and thorough education of nursing students about pain and its assessment, management, and evaluation. Further research needs to be conducted using the same methodology, but in a larger sample and in a variety of educational programs for professional nurses. Emphasis also needs to be on specific levels of pain assessment and adequate dosing of pain medication, as prescribed. The significant findings of this study need to be replicated using a larger sample and across a variety of educational programs for future professional nurses. Areas of concentration need to be on the adequate assessment of pain and its effective management. Additionally, there needs to be assessment of specific knowledge deficits about pain medications in regard to their specific action, indication(s), and dosing. Nonpharmacologic pain management therapies need to also be researched. With pain being one of the top priorities in health care settings, more research needs to occur so that future professional nurses are adequately prepared both in their knowledge and clinical skills in the assessment, planning, implementation, and evaluation of all types of patient pain experiences. Reference: Duke, G., Haas, B. K., Yarborough, S., & Northam, S. (2013). Pain management knowledge and attitudes of baccalaureate nursing 547 students and faculty. Pain Management Nursing, 14, 11–19. For patients receiving long-acting opioids, breakthrough pain often occurs between doses of pain medications. This is because the analgesic effects wear off as the drug is metabolized and eliminated from the body. Treatment with “prn” (as needed) doses of immediate-release dosage forms (e.g., oxycodone immediate release [IR]) given between scheduled doses of extended-release dosage forms (e.g., oxycodone ER is often helpful in these cases. Chewing or crushing of any extended-release opioid drug can cause oversedation, respiratory depression, and even death due to rapid drug absorption. If the patient is requiring larger doses for breakthrough pain, the dose of the scheduled extended-release opioid may need to be shortened or a more potent drug started. The US Food and Drug Administration (FDA) strongly encourages drug manufactures to produce long acting opioids with built in abuse deterrent properties. There are several different ways to achieve abuse deterrence and the student is referred to http://secure.medicalletter.org/w1476a for more information. Drugs from other chemical categories are often added to the opioid regimen as adjuvant drugs. These assist the primary drugs in relieving pain. Such adjuvant drug therapy may include NSAIDs (see Chapter 44), antidepressants (see Chapter 16), antiepileptic drugs (see Chapter 14), and corticosteroids (see Chapter 33). This approach allows the use of smaller dosages of opioids and reduces some of the adverse effects that are seen with higher dosages of opioids, such as respiratory depression, constipation, and urinary retention. It permits drugs with different mechanisms of action to produce synergistic effects. Antiemetics (see Chapter 52) and laxatives (see Chapter 51) may also be needed to prevent or relieve associated constipation, nausea, and vomiting (see the box Safety and Quality Improvement: Identifying Potential Opioid Adverse Effects). This multimodal approach has been shown to be very effective in treating pain. Safety and Quality Improvement 548 Identifying Potential Opioid Adverse Effects Constipation Opioids decrease gastrointestinal (GI) tract peristalsis because of their central nervous system (CNS) depression, with subsequent constipation as an adverse effect. Stool becomes excessively dehydrated because it remains in the GI tract longer. Preventative measures: Constipation may be managed with increased intake of fluids, stool softeners such as docusate sodium, or the use of stimulants such as bisacodyl or senna. Agents such as lactulose, sorbitol, and polyethylene glycol (Miralax) have been proven effective. Bulk-forming laxatives, such as psyllium, may be used but do require an increase in fluid intake to avoid fecal impactions or bowel obstructions. Nausea and Vomiting Opioids decrease GI tract peristalsis, and some also stimulate the vomiting center in the CNS, so nausea and vomiting are often experienced. Preventative measures: Nausea and vomiting may be managed with the use of antiemetics such as phenothiazines. Sedation and Mental Clouding Any change in mental status must always be evaluated to ensure that causes other than drug-related CNS depression are ruled out. Respiratory depression is strongly associated with excessive sedation. Preventative measures: Safety precautions implemented. Persistent drug-related sedation may be managed with a decrease in the dosage of opioid or change in drug used. The prescriber may also order various CNS stimulants (see Chapter 13). Respiratory Depression Long-term opioid use is generally associated with tolerance to respiratory depression. Preventative measures: For severe respiratory depression, an opioid antagonist (naloxone) may be needed. Subacute Overdose Subacute overdose may be more common than acute respiratory 549 depression and may progress slowly (over hours to days), with somnolence and respiratory depression. Before analgesic dosages are changed or reduced, advancing disease must be considered, especially in the dying patient. Preventative measures: Often, holding one or two doses of an opioid analgesic is enough to judge if the mental and respiratory depression is associated with the opioid. If there is improvement with this measure, the opioid dosage is often decreased by 25%. Other Opioid Adverse Effects Dry mouth, urinary retention, pruritus, dysphoria, euphoria, sleep disturbances, or sexual dysfunction may occur but are less common than the aforementioned adverse effects. Preventative measures: Ongoing assessment is needed for each of the adverse effects so that appropriate measures may be implemented (e.g., sucking of sugar-free hard candy or use of artificial saliva drops or gum for dry mouth; use of diphenhydramine for pruritus). Adjuvant drugs are commonly used in the treatment of neuropathic pain, where opioids are not completely effective. Neuropathic pain usually results from nerve damage secondary to disease (e.g., diabetic neuropathy, postherpetic neuralgia secondary to shingles, AIDS or injury, including nerve damage secondary to surgical procedures [e.g., post-thoracotomy pain syndrome occurring after cardiothoracic surgery]). Common symptoms include hypersensitivity or hyperalgesia to mild stimuli such as light touch or a pinprick, or the bed sheets on a person's feet. This is also known as allodynia. It can also manifest as hyperalgesia to uncomfortable stimuli, such as pressure from an inflated blood pressure cuff on a patient's limb. It may be described as heat, cold, numbness and tingling, burning, or electrical sensations. Examples of adjuvants commonly used in these cases are the antidepressant amitriptyline and the anticonvulsants gabapentin and pregabalin. The three-step analgesic ladder defined by the World Health Organization (WHO) is often applied as the pain management standard. Step 1 is the use of nonopioids (with or without adjuvant medications) once the pain has been identified and assessed. If pain persists and/or increases, treatment moves to step 2, which is 550 defined as the use of opioids with or without nonopioids and with or without adjuvants. If pain persists or increases, management then rises to step 3, which is the use of opioids indicated for moderate to severe pain, administered with or without nonopioids or adjuvant medications. Not all patients will be treated effectively using the ladder method, and some may need to seek an experienced pain management physician. Pharmacology Overview The terms opioids and narcotics are often used interchangeably. However, the appropriate term when discussing pharmacology is opioid. Law enforcement professionals use the term narcotics. Opioids are classified as both mild agonists (codeine, hydrocodone) and strong agonists (morphine, hydromorphone, oxycodone, meperidine, fentanyl, and methadone). Meperidine is not recommended for long-term use because of the accumulation of a neurotoxic metabolite, normeperidine, which can cause seizures. In 2010, the mild agonist propoxyphene (Darvocet) was withdrawn from the market due to adverse effects. The opiate agonistsantagonists such as pentazocine and nalbuphine are associated with an analgesic ceiling effect. This means that the drug reaches a maximum analgesic effect, so that analgesia does not improve even with higher dosages. Such drugs are useful only in patients who have not been previously exposed to opioids. Finally, because of associated bruising and bleeding risks, as well as injection discomfort, there is now a strong trend away from intramuscular injections in favor of intravenous, oral, and transdermal routes of drug administration. Opioid Drugs The pain-relieving drugs currently known as opioid analgesics originated from the opium poppy plant. The word opium is a Greek word that means “juice.” More than 20 different alkaloids are obtained from the unripe seed of the poppy. 551 Chemical Structure Opioid analgesics are very strong pain relievers. They can be classified according to their chemical structure or their action at specific receptors. Of the 20 different natural alkaloids available from the opium poppy plant, only 3 are clinically useful: morphine, codeine, and papaverine. Of these, only morphine and codeine are pain relievers; papaverine is a smooth muscle relaxant. Relatively simple synthetic chemical modifications of these opium alkaloids have produced the three different chemical classes of opioids: morphine-like drugs, meperidine-like drugs, and methadone-like drugs (Table 10.4). Knowing the chemical structure of the different opioids can be important in determining the appropriate drug for patients who experience significant allergic reactions to a specific opioid. For example, if a patient experiences anaphylaxis from morphine, giving a drug with an unrelated structure such as fentanyl would be appropriate. TABLE 10.4 Chemical Classification of Opioids Chemical Category Meperidine-like drugs Methadone-like drugs Morphine-like drugs Other Opioid Drugs meperidine, fentanyl, remifentanil, sufentanil, alfentanil Methadone morphine, heroin, hydromorphone, codeine, hydrocodone, oxycodone tramadol, tapentadol Mechanism of Action and Drug Effects Opioid analgesics can also be characterized according to their mechanism of action. They are agonists, agonists-antagonists, or antagonists (nonanalgesic). An agonist binds to an opioid pain receptor in the brain and causes an analgesic response—the reduction of pain sensation. An agonist-antagonist, also called a partial agonist or a mixed agonist, binds to a pain receptor and causes a weaker pain response than does a full agonist. Different 552 drugs in this class exert their agonist and/or antagonist effects by binding in different degrees to kappa and mu opioid receptors. Although not normally used as first-line analgesics, they are sometimes useful in pain management in obstetrical patients (because they avoid oversedation of the mother and/or fetus). An antagonist binds to a pain receptor but does not reduce pain signals. It functions as a competitive antagonist because it competes with and reverses the effects of agonist and agonist-antagonist drugs at the receptor sites. The receptors to which opioids bind to relieve pain are listed in Table 10.5. The mu, kappa, and delta receptors are most responsive to drug activity, with the mu being the most important. Many of the characteristics of a particular opioid, such as its ability to sedate, its potency, and its ability to cause hallucinations, can be attributed to relative affinity for these various receptors. TABLE 10.5 Opioid Receptors and Their Characteristics Receptor Type mu Prototypical Agonist morphine kappa delta ketocyclazocine Enkephalins Effects of Opioid Stimulation Supraspinal analgesia, respiratory depression, euphoria, sedation Spinal analgesia, sedation, miosis Analgesia Understanding the relative potencies of various drugs becomes important in clinical settings. Equianalgesia refers to the ability to provide equivalent pain relief by calculating dosages of different drugs and/or routes of administration that provide comparable analgesia. Box 10.2 lists equianalgesic doses for several common opioids and shows how to calculate dosage conversions for patients. For example, hydromorphone (Dilaudid) is seven times more potent than morphine. Deaths have been reported where a nurse gave the patient morphine and, not realizing the equianalgesic equivalency, gave the same patient hydromorphone a short time later. It is critical to understand that hydromorphone is seven times more potent than morphine. 553 Box 10.2 Calculating Dosage Conversions Between Commonly Used Opioids morphine EQUIANALGESIC DOSES Oral Parenteral Oral-to-Parenteral Dose Dose (mg) Dose Ratio (mg) 30 10 3:1 hydromorphone 7.5 1.5 5:1 oxycodone 15 N/A N/A hydrocodone 30 N/A N/A Dosing Interval (h) 12 (continuous release) 4 (immediate release) 4 (immediate release) 4 (immediate release) N/A Basic Conversion Equation where x= the amount of desired opioid in 24 hours and EA = the equianalgesic dose obtained from the table above. For example: A patient with colon cancer is currently taking oral oxycodone 80 mg every 12 hours and needs to be converted to intravenous morphine due to a bowel obstruction. What is the equivalent IV morphine dose? Step 1: Determine the 24-hour amount of oxycodone taken by this patient: 80 mg × 2 doses per 24 hours = 160 mg per 24 hours Step 2: Using the conversion table above, find the equianalgesic (EA) doses of oxycodone and parenteral morphine: 15 mg oxycodone = 10 mg parenteral morphine Step 3: Use the above equation and solve for x by crossmultiplying: 554 where x = the amount of parenteral morphine in 24 hours (solve by cross-multiplying). x = 107 mg (approximately 100 mg of injectable morphine per 24 hours) N/A, Not applicable. Indications The main use of opioids is to alleviate moderate to severe pain. The amount of pain control or unwanted adverse effects depends on the specific drug, the receptors to which it binds, and its chemical structure. Strong opioid analgesics such as fentanyl, sufentanil, and alfentanil are commonly used in combination with anesthetics during surgery. Use of fentanyl injection for management of postoperative and procedural pain has become popular due to its rapid onset and short duration. Transdermal fentanyl comes in a patch formulation for use in long-term pain management and is not to be used for postoperative or any other short-term pain control (see the box Safety and Quality Improvement: Preventing Medication Errors on p. 145). Safety and Quality Improvement: PREVENTING MEDICATION ERRORS Transdermal Fentanyl Patches When giving transdermal fentanyl patches, keep in mind several important points to avoid improper administration: 555 • These patches are recommended to be used only by patients who are considered opioid tolerant. Patients considered to be opioid-tolerant are those in severe pain requiring daily, roundthe-clock opioid treatment with alternative treatments being inadequate in pain control. • To be considered opioid tolerant, a patient needs to have been taking, for a week or longer, morphine 60 mg daily, or oral oxycodone 30 mg daily, or a minimum of 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid. Giving fentanyl transdermal patches to non–opioidtolerant patients may result in severe respiratory depression. Thorough assessment is important by qualified, licensed medical/nursing personnel. • It is recommended that transdermal fentanyl be prescribed only by health care professionals knowledgeable in the use of potent opioids for the treatment/management of chronic pain. • All other extended-released opioids must be discontinued or tapered prior to the initiation of transdermal fentanyl therapy, and, because it is to be used only in opioid-tolerant patients, it is not indicated to be begun as the first opioid of use. • The dosing regimen is to be initiated for each patient individually with the consideration of their prior analgesic treatment regimen(s) and risk for factors such as addiction, abuse, and misuse. • Once the medication regimen is begun, always monitor patients closely for respiratory depression especially within the initial 24 to 72 hours which is the timeframe for peak effects of serum concentrations of the transdermal fentanyl. ALL other “around-the-clock” opioids must be discontinued when the fentanyl is initiated. • Because of patient variability and even though there are dosage tables of opioid equivalents available, it is “preferable” to underestimate the patient's 24-hour fentanyl requirements and plan for the possible use of rescue medication, such as immediate-release opioids. • Inform patients that heat, such as in the form of a heating pad/pack, must never be applied over a transdermal fentanyl 556 patch. The increased circulation that results from the application of heat may result in increased absorption of medication, causing an overdose. • Teach about the proper disposal of transdermal patches. The patch is customarily applied externally for 72 hours and then replaced with a new patch. Although a used patch may have been applied for a 72-hour time period, it may still contain a significant amount of medication, which presents a tremendous health hazard/risk of accidental exposure (and even opportunity for diversion). • Extreme caution is to be used when there are children within the home environment with patients using transdermal fentanyl patches … or with any type of transdermal medication patch. There have been incidences where children have pulled used fentanyl patches from the trash, which has resulted in death due to exposure to the drug. Additionally, there have been incidents of a patch becoming displaced and then becoming adhered to the skin of an infant, toddler, or child under a variety of means. Respiratory depression and death are certainly the concern! • For disposal at home, the product insert recommends that the patch be folded in half and disposed of by flushing down the toilet (see www.fda.org for a complete listing of medicines recommended for disposal by flushing). For the home setting and other facilities, when a drug contains instructions to flush it down the toilet it is because the US Food and Drug Administration (FDA) has been working with the manufacturer regarding the most appropriate method of disposal presenting the least risk to safety (see www.fda.gov/ForConsumers/ConsumerUpdates). • Disposal practices in health care institutions may vary by area because of concerns for the water systems. Follow health care institution policy. • Accidental drug poisoning with transdermal fentanyl has also occurred in health care settings where children accompany adults to visit patients. This includes long-term care institutions, so it is extremely important that used patches are 557 disposed of very carefully and with the consideration of all institution drug-disposal policies. • Keep patches, as well as all medications, away from children and pets. • Do not store medications in warm, moist places such as medicine cabinets in the bathroom as this may result in degradation of the drug. • Encourage patient education through printed and verbal instructions. • The Institute for Safe Medication Practices has described examples of fatal patient incidents resulting from failure to follow the above points. It is essential for the patient's safety to read the product labeling and follow instructions precisely. For more information, visit www.ismp.org. Strong opioids such as morphine, hydromorphone, and oxycodone are often used to control postoperative and other types of pain. Because morphine and hydromorphone are available in injectable forms, they are often first-line analgesics in the immediate postoperative setting. There is a trend away from using meperidine due to its greater risk for toxicity (see the Drug Profile). All available oxycodone dosage forms are orally administered. The product OxyContin is a sustained-release form of oxycodone that is designed to last up to 12 hours. The “Contin” in the product name is a trademark of the original drug manufacturer, and refers to the “continuous-release” nature of the drug formulation. Recall that a continuous- or extended-release dosage form of a drug means that it has a prolonged duration of action, most often 8 to 24 hours (see Chapter 2). Similarly, the drug product MS Contin is a long-acting or sustained-release form of morphine. The “MS” stands for morphine sulfate. Both drugs are also available generically. In 2013, the FDA approved a risk evaluation and mitigation strategy (REMS) for long-acting opioids. The FDA requires prescriber and patient education to help combat prescription opioid misuse and deaths. There are also immediate-release dosage forms of oxycodone and morphine in tablet, capsule, and liquid form. The analgesic effects 558 of immediate-release oral dosage forms of all three drugs typically last for about 4 hours. Opioids also suppress the medullary cough center, which results in cough suppression. The most commonly used opioid for this purpose is codeine (see Chapter 36). Hydrocodone is also used in many cough suppressants, either alone or in combination with other drugs. Constipation is often an unwanted side effect of opioids due to decreased gastrointestinal (GI) tract motility. It occurs because opioid drugs bind to intestinal opioid receptors. However, this effect is sometimes helpful in treating diarrhea. Some of the opioid-containing antidiarrheal preparations are camphorated opium tincture (paregoric) and diphenoxylate/atropine (Lomotil) tablets. Contraindications Contraindications to the use of opioid analgesics include known drug allergy and severe asthma. It is not uncommon for patients to state they are allergic to codeine, when in the overwhelming majority of these patients nausea was the “allergic” reaction. Many patients will claim to be allergic to morphine because it causes itching. Itching is a pharmacologic effect due to histamine release and not an allergic reaction. Thus it is important to determine the exact nature of a patient's stated allergy. Although not absolute contraindications, extreme caution is to be used in cases of respiratory insufficiency, especially when resuscitative equipment is not available and in conditions involving elevated intracranial pressure (e.g., severe head injury); morbid obesity and/or sleep apnea; myasthenia gravis; paralytic ileus (bowel paralysis); and pregnancy, especially with long-term use or high dosages. Adverse Effects Many of the unwanted effects of opioid analgesics are related to their pharmacologic effects in areas other than the CNS. Some of these unwanted effects can be explained by the drug's selectivity for the receptors listed in Table 10.5. The various body systems that the opioids affect and their specific adverse effects are summarized in Table 10.6. 559 TABLE 10.6 Opioid-Induced Adverse Effects by Body System Body System Cardiovascular Central nervous Gastrointestinal Genitourinary Integumentary Respiratory Adverse Effects Hypotension, flushing, bradycardia Sedation, disorientation, euphoria, lightheadedness, dysphoria Nausea, vomiting, constipation, biliary tract spasm Urinary retention Itching, rash, wheal formation Respiratory depression and possible aggravation of asthma Opioids that have an affinity for mu receptors and have rapid onset of action produce marked euphoria, and are most likely to be abused. All opioid drugs have a strong abuse potential. They are common recreational drugs of abuse among the lay public and also among health care professionals, who often have relatively easy access. The person taking them to alter his or her mental status will soon become psychologically dependent (addicted; see Chapter 17). The FDA now requires a black box warning on all IR and longacting opioids. In addition, opioids cause histamine release. It is thought that this histamine release is responsible for many of the drugs’ unwanted adverse effects, such as itching or pruritus, rash, and hemodynamic changes. Histamine release causes peripheral arteries and veins to dilate, which leads to flushing and orthostatic hypotension. The amount of histamine release that an opioid analgesic causes is related to its chemical class. The naturally occurring opiates (e.g., morphine) elicit the most histamine release; the synthetic opioids (e.g., meperidine) elicit the least histamine release. (See Table 10.4 for a list of the various opioids and their respective chemical classes.) The most serious adverse effect of opioid use is CNS depression, which may lead to respiratory depression. When death occurs from opioid overdose, it is almost always due to respiratory depression. When opioids are given, care must be taken to titrate the dose so that the patient's pain is controlled without affecting respiratory function. Individual responses to opioids vary, and patients may occasionally experience respiratory compromise despite careful dose titration. Respiratory depression can be prevented in part by 560 using drugs with very short duration of action and no active metabolites. Respiratory depression seems to be more common in patients with a preexisting condition causing respiratory compromise, such as asthma, chronic obstructive pulmonary disease, or sleep apnea. Respiratory depression is strongly related to the degree of sedation (see the section Toxicity and Management of Overdose later in the chapter). GI tract adverse effects are common in patients receiving opioids due to stimulation of GI opioid receptors. Nausea, vomiting, and constipation are the most common adverse effects. Opioids can irritate the GI tract, stimulating the chemoreceptor trigger zone in the CNS, which in turn may cause nausea and vomiting. Opioids slow peristalsis and increase absorption of water from intestinal contents. These two actions combine to produce constipation. This is more pronounced in hospitalized patients who are nonambulatory. Patients may require laxatives (see Chapter 51) to help maintain normal bowel movements. Three drugs, naloxegol (Movantik), methylnaltrexone, (Relistor) and naldemedine (Symproic) are indicated specifically for opioid-induced constipation. They are usually used in patients taking opioids chronically. Urinary retention, or the inability to void, is another unwanted adverse effect of opioids, caused by increasing bladder tone. Severe hypersensitivity or anaphylactic reaction to opioid analgesics is rare. Many patients will experience GI discomforts or histamine-mediated reactions to opioids and call these “allergic reactions.” However, true anaphylaxis is rare, even with intravenously administered opioids. Some patients may complain of flushing, itching, or wheal formation at the injection site, but this is usually local and histamine mediated, and not a true allergy. See the box Safety and Quality Improvement: Identifying Potential Opioid Adverse Effects on p. 142 for additional information on opioid adverse effects and their management. Toxicity and Management of Overdose Naloxone and naltrexone are opioid antagonists, and they bind to and occupy all of the receptor sites (mu, kappa, delta). They are competitive antagonists with a strong affinity for these binding sites. Through such binding, they can reverse the adverse effects 561 induced by the opioid drug, such as respiratory depression. Naloxone is used in the management of opioid overdose. Naltrexone is used for alcohol and opioid addiction. Naloxone can also be used in small doses to treat itching associated with opioid use. Some degree of physical dependence is expected in opioidtolerant patients. The extent of opioid tolerance is most visible when an opioid drug is discontinued abruptly or when an opioid antagonist is administered. This usually leads to symptoms of opioid withdrawal, also known as abstinence syndrome (see Chapter 17). This can occur after as little as 2 weeks of opioid therapy in opioid naive patients. Gradual dosage reduction after chronic opioid use, when possible, helps to minimize the risk and severity of withdrawal symptoms. Respiratory depression is the most serious adverse effect associated with opioids. Stimulating the patient may be adequate to reverse mild hypoventilation. If this is unsuccessful, ventilatory assistance using a bag and mask or endotracheal intubation may be needed to support respiration. Administration of opioid antagonists (e.g., naloxone) may also be necessary to reverse severe respiratory depression. Careful titration of dose until the patient begins to breathe independently will prevent over-reversal. The effects of naloxone are short-lived and usually last about 1 hour. With longacting opioids, respiratory depressant effects may reappear, and naloxone may need to be re-dosed periodically until symptoms resolve. The onset of withdrawal symptoms is directly related to the halflife of the opioid analgesic being used. Withdrawal symptoms resulting from the discontinuance or reversal of therapy with shortacting opioids (codeine, hydrocodone, morphine, and hydromorphone) will appear within 6 to 12 hours and peak at 24 to 72 hours. Withdrawal symptoms associated with the long half-life drugs (methadone, levorphanol, and transdermal fentanyl) may not appear for 24 hours or longer after drug discontinuation and may be milder. Interactions 562 Potential drug interactions with opioids are significant. Coadministration of opioids with alcohol, antihistamines, barbiturates, benzodiazepines, phenothiazine, and other CNS depressants can result in additive respiratory depressant effects. The combined use of opioids, such as meperidine, with monoamine oxidase inhibitors, such as selegiline, can result in respiratory depression, seizures, and hypotension. In 2016, the FDA issued a black box warning for all opioids and all benzodiazepines regarding the risk of combined use. The combination should be used only if no other alternatives are available. Risks include extreme sleepiness, respiratory depression, coma, and death. Laboratory Test Interactions Opioids can cause an abnormal increase in the serum levels of amylase, alanine aminotransferase, alkaline phosphatase, bilirubin, lipase, creatinine kinase, and lactate dehydrogenase (see the box Safety: Laboratory Values Related to Drug Therapy on the next page). Other abnormal results include a decrease in urinary 17ketosteroid levels and an increase in the urinary alkaloid and glucose concentrations. Dosages For the recommended initial dosages of selected analgesic drugs in opioid-naïve patients, see the dosages table on the next page. Safety: Laboratory Values Related to Drug Therapy Analgesics Laboratory Test Alkaline phosphatase (ALP) Normal Ranges 30–120 units/L Rationale for Assessment ALP is found in many tissues but in highest concentrations in the liver, biliary tract, and bone. Detection of this enzyme is important for determining liver and bone disorders. Enzyme levels of ALP are increased in both extrahepatic 563 and intrahepatic obstructive biliary disease and cirrhosis and/or other liver abnormalities. Alanine 4–36 units/L ALT is found mainly in the liver and lesser aminotransferase Older amounts in the kidneys, heart, and skeletal muscle. (ALT); formerly adults may If there is injury or disease to the liver parenchyma serum glutamic- have (cells), it will cause a release of this liver cellular pyruvic slightly enzyme into the bloodstream and thus elevate transaminase higher serum ALT levels. Most ALT elevations are from (SGPT) levels than liver disease. Therefore, if medications are then the adult metabolized by the liver, this metabolic process will be altered and possibly lead to toxic levels of drugs. Gama-glutamyl Male/female GGT is an enzyme that is present in liver tissue; transferase 45 years of when there is damage to the liver cells (GGT) age and (hepatocytes) that manufacture bile, the enzyme older: 8–38 will be released throughout the cell membranes units/L and released into the blood. Individuals of African ancestry have normal values that are double the values of those who are white. Aspartate 0–35 units/L AST is elevated with hepatocellular diseases. With aminotransferase disease or injury of liver cells, the cells lyse and the (AST); formerly AST is released and picked up by the blood; the called serum elevation of AST is directly related to the number glutamicof cells affected by disease or injury. oxalocetic transaminase (SGOT) Lactic 100–190 LDH is found in cells of many body tissues dehydrogenase units/L including the heart, liver, red blood cells, kidneys, (LDH) skeletal muscles, brain, and lungs. Because it is in so many tissues, the total LDH level is not a specific indicator of one disease. If there is disease or injury affecting cells containing LDH, the cells lyse and LDH is released from the cells into the bloodstream, thus increasing LDH levels. This enzyme is just part of the total picture of altered liver function, which, if present, will then decrease the breakdown/metabolism of drugs and other chemical compounds, resulting in elevated blood levels of drugs. Dosages Selected Analgesic Drugs and Related Drugs Drug (Pregnancy Pharmacologic Usual Adult Dosage Class Range 564 Indications/Uses Category) Opioids codeine sulfate (D) fentanyl (Duragesic, Oralet, Actiqa) (D) Class Range Opiate analgesic; opium alkaloid Opioid analgesic 15–60 mg tid-qid 10–20 mg every 4–6 hr; do not exceed 120 mg/day All doses titrated to response, starting with lowest effective dose IV/IM: 50–100 mcg/dose titrated to response via continuous infusion. Duragesic (transdermal patch): 12–200 mcg/hr every 72 hr; Oralet, Actiq (buccal lozenges): begin with lowest dose (200 mcg) and titrate as needed NOTE: The FDA has placed restrictions on transmucosal fentanyl (only allowed for chronic pain) IV/IM: 0.25–1 mg IV every 4–6 hr prn Oral: 2–4 mg PO every 6 hr prn hydromorphone Opioid (Dilaudid) analgesic meperidine HCl Opioid (Demerol) (D) analgesic methadone HCl Opioid (Dolophine) (D) analgesic morphine Opiate sulfate (MSIR, analgesic; Roxanol, others) opium Opioid analgesia Relief of cough Procedural sedation or adjunct to general anesthesia Relief of moderate to severe acute pain Relief of chronic pain, including cancer pain Seven times more potent than morphine. 1 mg hydromorphone = 7 mg morphine PO/IV/IM/subQ: 50–150 Meperidine use not mg every 3–4 hr prn recommended because of the unpredictable effects of neurometabolites at analgesic doses and risk for seizures PO/IM/IV/subQ: 2.5– Opioid analgesia, 10 mg every 8–12 hr relief of chronic 40 mg or more once pain, opioid daily detoxification Opioid addiction maintenance PO: 10–30 mg every 4 Opioid analgesia hr prn IV/IM/subQ: 2.5–10 565 Roxanol, others) (D) morphine sulfate, continuousrelease (MS Contin, Oramorph, Kadian) (D) oxycodone, immediaterelease (OxyIR) (D) oxycodone, continuousrelease (OxyContin) (D) opium alkaloid Opiate analgesic; opium alkaloid IV/IM/subQ: 2.5–10 mg every 2–6 hr prn PO: 15 mg every 8 hr to 200 mg every 8–12 hr Opioid, synthetic PO: 5–20 mg every 4–6 hr Relief of moderate to prn severe pain Opioid, synthetic PO: 10–160 mg every 8– 12 hr Relief of moderate to severe pain Cannot be crushed IV: 0.4–2 mg IV; repeat in 2–8 min if needed IV: 0.1–0.2 mg IV; repeat at 2–3 min intervals Treatment of opioid overdose Postoperative anesthesia reversal Opioid Antagonists naloxone HCl Opioid (Narcan) antagonist Nonopioids acetaminophen Nonopioid (Tylenol, others) analgesic, (B) antipyretic tramadol (Ultram) PO/PR: 325–650 mg every 4–6 hr not to exceed 3–4 g/day In alcoholics, not to exceed 2 g/day Nonopioid PO: 50–100 mg every 4–6 analgesic (with hr not to exceed 400 opioid-like mg/day activity) Relief of moderate to severe pain Cannot be crushed Relief of mild to moderate pain Relief of moderate to moderately severe pain a Actiq is not approved for use in patients younger than 16 years of age. FDA, US Food and Drug Administration; HCl, hydrochloride; IM, intramuscular; IV, intravenous; IR, immediate release; MS, morphine sulfate; MSIR, morphine sulfate immediate-release; PCA, patient-controlled analgesia; PO, oral; PR, rectal; subQ, subcutaneous. The maximum recommended daily dose of acetaminophen for a typical adult patient with normal liver function is 3000 mg/24 hr. For hepatically compromised patients, this dosage may be 2000 mg or even lower. If in doubt, check with a pharmacist or prescriber. 566 Drug Profiles Opioid Agonists codeine sulfate Codeine sulfate is a natural opiate alkaloid (Schedule II) obtained from opium. It is similar to morphine in terms of its pharmacokinetic and pharmacodynamic properties. In fact, about 10% of a codeine dose is metabolized to morphine in the body. However, codeine is less effective as an analgesic and is the only agonist to possess a ceiling effect (meaning increasing the dose will not increase response). It is more commonly used as an antitussive drug in an array of cough preparations (see Chapter 36). Codeine combined with acetaminophen (tablets or elixir) is classified as a Schedule III controlled substance and is commonly used for control of mild to moderate pain as well as cough. When codeine is not combined with other drugs, it is classified as a Schedule II controlled substance, which implies a high abuse potential. Codeine causes gastrointestinal (GI) tract upset, and many patients will say they are allergic to codeine, when in fact it just upsets their stomach. Codeine is contraindicated pediatric patients, laboring or breast feeding mothers. For dosage information, see the table on the previous page. Pharmacokinetics: Codeine Route PO Onset of Action 15–30 min Peak Plasma Concentration 34–45 min Elimination Half- Duration of Life Action 2.5–4 hr 4–6 hr PO, Oral. fentanyl Fentanyl is a synthetic opioid (Schedule II) used to treat moderate to severe pain. Like other opioids, it also has a high abuse potential. It is available in several dosage forms: parenteral injections, transdermal patches (Duragesic), buccal lozenges (Fentora), and buccal lozenges on a stick (Actiq). The buccal dosage forms are absorbed through the oral mucosa. The injectable form is used most 567 commonly in perioperative settings and in intensive care unit settings for sedation during mechanical ventilation. Fentanyl is a very potent analgesic. Fentanyl in a dose of 0.1 mg intravenously is roughly equivalent to 10 mg of morphine intravenously. The transdermal delivery system (patch) has been shown to be highly effective in the treatment of various chronic pain syndromes such as cancer-induced pain, especially in patients who cannot take oral medications. This route is not to be used in opioid-naïve patients or for acute pain relief. Fentanyl patches are difficult to titrate and are best used for nonescalating pain. Fentanyl patches take 6 to 12 hours to reach steady-state pain control after the first patch is applied, and supplemental short-acting therapy may be required. Most patients will experience adequate pain control for 72 hours with this method of fentanyl delivery. A new patch is to be applied every 72 hours. It is important to remove the old patch when applying a new one. It takes about 17 hours for the amount of fentanyl to reduce by 50% once the patch is removed. The US Food and Drug Administration (FDA) has issued many safety warnings about the use of fentanyl patches. Fentanyl patches are intended for management of chronic or cancer pain in opioidtolerant patients whose pain is not adequately controlled by other types of medications. These patches are not to be used for acute pain situations such as postoperative pain. According to the FDA, patients who are considered opioid tolerant are those who have been taking at least 60 mg of oral morphine daily or at least 30 mg of oral oxycodone daily or at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid. Other hazards associated with the use of fentanyl patches are cutting the patch and exposing the patch to heat (e.g., via a heating pad or sauna), both of which accelerate the diffusion of the drug into the patient's body. Unused patches should be flushed down the toilet. Fentanyl patches are often cut into pieces and sold on the street as “chicklets.” Patients should be warned to keep all fentanyl patches away from children, as deaths have occurred when toddlers inadvertently chewed fentanyl patches. For dosage information, see the table on p. 147. Pharmacokinetics: Fentanyl 568 Route Onset of Action IV Rapid Transdermal 12–24 hr PO 5–15 min Peak Plasma Concentration Elimination Half-Life Duration of Action Minutes 48–72 hr 20–30 min 1.5–6 hr Delayed 5–15 hr 30–60 min 13–40 hr Unknown hydromorphone (Dilaudid) Hydromorphone (Dilaudid) is a very potent opioid analgesic and is a Schedule II drug. It is approximately seven times more potent than morphine. It is often referred to as Dilaudid, because hydromorphone can be mistaken for morphine. One milligram of IV or IM hydromorphone is equivalent to 7 mg of morphine. Many nurses are unfamiliar with the potency difference, and because it is given in low doses (0.2–1 mg) some inadvertently assume low dose means low potency. Many medication errors and deaths have occurred because of lack of knowledge of this potency difference. Exalgo is the osmotic extended release oral delivery system of hydromorphone, which is difficult to crush or extract for injection, to help reduce the abuse potential. For dosage information, see the table on p. 147. Pharmacokinetics: Hydromorphone (Dilaudid) Route IV Onset of Action Rapid Peak Plasma Concentration 10–20 min Elimination Half- Duration of Life Action 2–3 hr 3–4 hr meperidine hydrochloride Meperidine hydrochloride (Demerol) is a synthetic opioid analgesic (Schedule II). Meperidine must be used with caution, if at all, in older adult patients and in patients who require long-term analgesia or who have kidney dysfunction. An active metabolite, normeperidine, can accumulate to toxic levels and lead to seizures. For this reason, meperidine is now rarely used and is not recommended for long-term pain treatment. However, it is still used in emergency department settings for acute migraine headaches and in the immediate postoperative period to reduce shivering. Meperidine is available in oral and injectable forms. For 569 Pharmacokinetics: Meperidine Onset of Route Action Peak Plasma Concentration Elimination Half- Duration of Life Action IM 30–60 min 3–5 hr Rapid 2–4 hr methadone hydrochloride Methadone hydrochloride (Dolophine) is a synthetic opioid analgesic (Schedule II). It is the opioid of choice for the detoxification treatment of opioid addicts in methadone maintenance programs. Methadone is readily absorbed through the GI tract with peak plasma concentrations at 4 hours for single dosing. It is unique in that its half-life is longer than its duration of action because it is bound into the tissues of the liver, kidneys, and brain. With repeated doses, the drug accumulates in these tissues and is slowly released, thus allowing for 24-hour dosing. Methadone is eliminated through the liver, which makes it a safer choice than some other opioids for patients with renal impairment. Recent FDA reports have cited the prolonged half-life of the drug as a cause of unintentional overdoses and deaths. There is also concern that methadone may cause cardiac dysrhythmias. Methadone is available in oral and injectable forms. For dosage information, see the table on p. 148. Pharmacokinetics: Methadone Route PO Onset of Action 30–60 min Peak Plasma Concentration 1.5–2 hr Elimination Half- Duration of Life Action 25 hr 22–48 hr morphine sulfate Morphine, a naturally occurring alkaloid derived from the opium poppy, is the drug prototype for all opioid drugs. It is classified as a Schedule II controlled substance. Morphine is indicated for severe pain and has a high abuse potential. It is available in oral, injectable, and rectal dosage forms. Extended-release forms include MS Contin and Kadian. Morphine also has a potentially toxic metabolite known as morphine-6-glucuronide. Accumulation of this metabolite is 570 known as morphine-6-glucuronide. Accumulation of this metabolite is more likely to occur in patients with renal impairment. For this reason, other Schedule II opioids such as hydromorphone (Dilaudid) and fentanyl may be safer analgesic choices for patients with renal insufficiency. Morphine is available in oral, rectal, epidural, and injectable dosage forms, including patient-controlled analgesia (PCA) cartridges. Embeda (morphine and naltrexone) is the newest morphine product. For dosage information, see the table on p. 148. Pharmacokinetics: Morphine Sulfate Route IV Onset of Action 5–10 min Peak Plasma Concentration 30 min Elimination Half- Duration of Life Action 2–4 hr 4 hr oxycodone hydrochloride Oxycodone hydrochloride is an analgesic drug that is structurally related to morphine and has comparable analgesic activity (Schedule II). It is also commonly combined in tablets with acetaminophen (Percocet) and with aspirin (Percodan). Oxycodone is also available in immediate-release formulations (Oxy IR) and sustained-released formulations (OxyContin). A somewhat weaker but commonly used opioid is hydrocodone, most commonly in combination with acetaminophen (Vicodin, Norco). There are also long-acting hydrocodone products with abuse deterrent properties, including Hysingla ER and Zyhydro ER. In 2014, hydrocodone was rescheduled as a CII drug. For dosage information, see the table on p. 148. Pharmacokinetics (Immediate Release): Oxycodone Hydrochloride Route PO Onset of Action 10–15 min Peak Plasma Concentration 1 hr Elimination Half- Duration of Life Action 2–3 hr 3–6 hr Opioid Agonists-Antagonists 571 (Schedule IV). They bind to the mu receptor and compete with other substances for these sites. They either exert no action (i.e., they are competitive antagonists) or have only limited action (i.e., they are partial agonists). They are similar to the opioid agonists in terms of their therapeutic indications; however, they have a lower risk for misuse and addiction. The antagonistic activity of this group can produce withdrawal symptoms in patients who are opioid-dependent. Their use is contraindicated in patients who have shown hypersensitivity reactions to the drugs. These drugs have varying degrees of agonist and antagonist effects on the different opioid receptor subtypes. They are used in situations requiring short-term pain control, such as after obstetric procedures. They are sometimes chosen for patients who have a history of opioid addiction. These medications can both help prevent overmedication and reduce posttreatment addictive cravings in these patients. Combination products of buprenorphine and naloxone offer physicians an in-office treatment of addiction (see Chapter 17). These drugs are normally not strong enough for management of longer-term chronic pain (e.g., cancer pain, chronic lower back pain). They are not to be given concurrently with full opioid agonists, because they may both reduce analgesic effects and cause withdrawal symptoms in opioid-tolerant patients. Adverse reactions are similar to opioids but with a lower incidence of respiratory depression. Four opioid agonists-antagonists are currently available: buprenorphine (Buprenex), butorphanol (Stadol), nalbuphine (Nubain), and pentazocine (Talwin). They are available in various oral, injectable, and intranasal dosage forms. A new transdermal form of buprenorphine (Butrans) is also available. Opioid Antagonists Opioid antagonists produce their antagonistic activity by competing with opioids for central nervous system (CNS) receptor sites. naloxone hydrochloride Naloxone hydrochloride (Narcan) is a pure opioid antagonist. It has no agonistic morphine-like properties and works as a blocking drug 572 no agonistic morphine-like properties and works as a blocking drug for the opioid drugs. Accordingly, the drug does not produce analgesia or respiratory depression. Naloxone is the drug of choice for the complete or partial reversal of opioid-induced respiratory depression. It is also indicated in cases of suspected acute opioid overdose. Failure of the drug to significantly reverse the effects of the presumed opioid overdose indicates that the condition may not be related to opioid overdose. The primary adverse effect is opioid withdrawal syndrome, which can occur with abrupt over-reversal in opioid-tolerant patients. Adverse effects include raised or lowered blood pressure, dysrhythmias, pulmonary edema, and withdrawal. Naloxone is available only in injectable dosage forms. Since 2016, naloxone has become available without a prescription and is being used by first responders for people who have overdosed, either on prescription opioids or on illegal drugs. First responders and anyone who knows of someone who may overdose utilize the IV form of naloxone with a nasal adapter. Use of the drug is contraindicated in patients with a history of hypersensitivity to it. Naltrexone is also an opioid antagonist; however it is available only orally and is used for alcohol and opioid addiction. For dosage information, see the table on p. 148. Pharmacokinetics: Naloxone Hydrochloride Route IV Onset of Action Less than 2 min Peak Plasma Concentration Rapid Elimination Half- Duration of Life Action 64 min 0.5–2 hr Nonopioid and Miscellaneous Analgesics Acetaminophen (Tylenol) is the most widely used nonopioid analgesic. Acetaminophen is commonly abbreviated APAP in the United States; however, this abbreviation is not recognized in Canada. There is a current movement to stop using APAP as an abbreviation, because of the potential that patients will not realize they are receiving a prescription with acetaminophen and may take 573 All of the drugs in the NSAID class (which includes aspirin, ibuprofen, naproxen, the cyclooxygenase-2 [COX-2] inhibitor celecoxib [Celebrex], and others) are nonopioid analgesics. These drugs are discussed in Chapter 44. They are used for management of pain, especially pain associated with inflammatory conditions such as arthritis, because they have significant antiinflammatory effects in addition to their analgesic effects. Miscellaneous analgesics include tramadol and transdermal lidocaine and are discussed in depth in their respective drug profiles in this chapter. Capsaicin is a topical product made from several different types of peppers. It works by decreasing or interfering with substance P, a pain signal in the brain. Capsaicin is available over the counter. It can be used for muscle pain, joint pain, and nerve pain. Milnacipran (Savella) is a selective serotonin and norepinephrine dual-uptake inhibitor. It is indicated for the treatment of fibromyalgia. It is thought that patients with fibromyalgia have reduced levels of norepinephrine in their brains, and milnacipran increases norepinephrine levels, which helps reduce pain associated with the disease. Mechanism of Action and Drug Effects The mechanism of action of acetaminophen is similar to that of the salicylates. It blocks peripheral pain impulses by inhibition of prostaglandin synthesis. Acetaminophen also lowers febrile body temperatures by acting on the hypothalamus, the structure in the brain that regulates body temperature. Heat is dissipated through vasodilation and increased peripheral blood flow. In contrast to NSAIDs, acetaminophen lacks antiinflammatory effects. Although acetaminophen shares the analgesic and antipyretic effects of the salicylates and other NSAIDs, it does not have many of the unwanted effects of these drugs. For example, acetaminophen products are not usually associated with cardiovascular effects (e.g., edema) or platelet effects (e.g., bleeding), as are aspirin and other NSAIDs. It also does not cause the aspirin-related GI tract irritation or bleeding, nor any of the aspirin-related acid-base changes. Indications 574 Indications Acetaminophen is indicated for the treatment of mild to moderate pain and fever. It is an appropriate substitute for aspirin because of its analgesic and antipyretic properties. Acetaminophen is also the antipyretic (antifever) drug of choice in children and adolescents with flu syndromes, because the use of aspirin in these populations is associated with a condition known as Reye's syndrome. It is also a valuable alternative for patients who cannot tolerate aspirin. Contraindications Contraindications to acetaminophen use include known drug allergy, severe liver disease, and the genetic disease known as glucose-6-phosphate dehydrogenase (G6PD) deficiency. Adverse Effects Acetaminophen is generally well tolerated and is therefore available over the counter and in many combination prescription drugs. Possible adverse effects include skin disorders, nausea, and vomiting. Much less common but more severe are the adverse effects of blood disorders or dyscrasias (e.g., anemias) and nephrotoxicities, and hepatotoxicity. Hepatotoxicity is the most serious adverse effect of acetaminophen. Hepatotoxicity is associated with excessive doses. Acetaminophen is combined with hydrocodone (Vicodin, Norco) or oxycodone (Percocet, Tylox), and patients may exceed the recommended limit of acetaminophen without knowing these products also contain acetaminophen. In 2011, the FDA announced that combination products are to be limited to 325 mg of acetaminophen. Currently, the FDA limits total daily doses to 4000 mg; however, the manufacturer of Tylenol suggests a limit of 3000 mg/day. Patients with liver disease or chronic alcohol consumption are advised not to exceed 2000 mg/day. Toxicity and Management of Overdose Many people do not realize that acetaminophen, despite its overthe-counter status, is a potentially lethal drug when taken in 575 intentionally overdose on the drug as an attention-seeking gesture without realizing the grave danger involved. The ingestion of large amounts of acetaminophen, as in acute overdose, or chronic unintentional misuse can cause hepatic necrosis. Acute ingestion of acetaminophen doses of 150 mg/kg (approximately 7 to 10 g) or more may result in hepatotoxicity. Acute hepatotoxicity can usually be reversed with acetylcysteine, whereas long-term toxicity is more likely to be permanent. The long-term ingestion of large doses of acetaminophen is likely to result in severe hepatotoxicity, which may be irreversible. Because the reported quantity of drug ingested is often inaccurate, a serum acetaminophen concentration is determined no sooner than 4 hours after ingestion. If a serum acetaminophen level cannot be determined, it is assumed that the overdose is potentially toxic and treatment with acetylcysteine needs to be started. Acetylcysteine is the recommended antidote for acetaminophen toxicity and works by preventing the hepatotoxic metabolites of acetaminophen from forming. It is most effective when given within 10 hours of an overdose. Oral acetylcyste is notoriously bad tasting with an odor of rotten eggs, and vomiting of an oral dose is common. It is recommended that the dose be repeated if vomiting occurs within 1 hour of dosing. An intravenous dosage formulation of acetylcysteine (Acetadote) is also available and much better tolerated by the patient. Interactions A few drugs interact with acetaminophen. Alcohol is potentially the most dangerous. Chronic heavy alcohol abusers may be at increased risk of liver toxicity from excessive acetaminophen use. For this reason, a maximum daily dose of 2000 mg is generally recommended for such patients. Health care professionals need to warn patients with regular intake of alcohol not to exceed recommended dosages of acetaminophen because of the risk for liver dysfunction and possible liver failure. Ideally, alcohol consumption is not to exceed three drinks daily. Other hepatotoxic drugs need to be avoided. Other drugs that potentially can interact with acetaminophen include phenytoin, barbiturates, warfarin, 576 with acetaminophen include phenytoin, barbiturates, warfarin, isoniazid, rifampin, beta blockers, and anticholinergic drugs, all of which are discussed in greater detail in later chapters. Drug Profiles acetaminophen Acetaminophen (Tylenol) is an effective and relatively safe nonopioid analgesic used for mild to moderate pain relief. It is best avoided in patients who are alcoholic or who have hepatic disease. Acetaminophen is available in oral, rectal, and most recently, intravenous (IV) form. Acetaminophen is also a component of several prescription combination drug products, including hydrocodone/acetaminophen (Vicodin) and oxycodone/acetaminophen (Percocet). Pharmacokinetics: Acetaminophen Route PO Onset of Action 10–30 min Peak Plasma Concentration 0.5–2 hr Elimination Half- Duration of Life Action 1–4 hr 3–4 hr tramadol hydrochloride Tramadol hydrochloride (Ultram) is categorized as a miscellaneous analgesic due to its unique properties. It is a centrally acting analgesic with a dual mechanism of action. It creates a weak bond to the mu opioid receptors and inhibits the reuptake of both norepinephrine and serotonin. Although it does have weak opioid receptor activity, tramadol is not currently classified as a controlled substance. Tramadol is indicated for the treatment of moderate to moderately severe pain. Tramadol is rapidly absorbed, and its absorption is unaffected by food. It is metabolized in the liver to an active metabolite and eliminated via renal excretion. Adverse effects are similar to those of opioids and include drowsiness, dizziness, headache, nausea, constipation, and respiratory depression. Seizures have been reported in patients taking tramadol and can occur in patients taking both normal and excessive 577 tricyclic antidepressants, selective serotonin reuptake inhibitors (SSRIs), monoamine oxidase inhibitors, neuroleptics, or other drugs that reduce the seizure threshold. There is also an increased risk for developing serotonin syndrome when tramadol is taken concurrently with SSRIs (see Chapter 16). In 2014, tramadol was rescheduled to a class CIV narcotic by the federal government, although certain states consider tramadol a CII or CIII drug. Use of tramadol is contraindicated in cases of known drug allergy, which may include allergy to opioids due to potential cross-reactivity. The drug is only available in oral dosage forms, including a combination with acetaminophen (Ultracet), as well as extendedrelease formulation (ConZip, Ryzolt, Ultram ER) and as an orally disintegrating tablet called Rybix. A new drug, tapentadol (Nucynta), is structurally related to tramadol with a dual mechanism of action. It is a mu agonist and a norepinephrine reuptake inhibitor. It is a Schedule II narcotic. Pharmacokinetics: Tramadol Route PO Onset of Action 30 min Peak Plasma Concentration 2 hr Elimination Half- Duration of Life Action 5–8 hr 6 hr lidocaine, transdermal Transdermal lidocaine is a topical anesthetic (see Chapter 11) that is formulated into a patch (Lidoderm) and is placed onto painful areas of the skin. It is indicated for the treatment of postherpetic neuralgia, a painful skin condition that remains after a skin outbreak of shingles. Lidocaine patches provide local pain relief, and up to three patches may be placed on a large painful area. The patches are not to be worn for longer than 12 hours a day to avoid potential systemic drug toxicity (e.g., cardiac dysrhythmias). Because they act topically, there are minimal systemic adverse effects. However, the skin at the site of treatment may develop redness or edema, and unusual skin sensations may occur. These reactions are usually mild and transient and resolve within a few minutes to hours. Patches are applied only to intact skin with no blisters. They can be used either alone or as part of adjunctive treatment with systemic therapies such as antidepressants (see 578 treatment with systemic therapies such as antidepressants (see Chapter 16), opioids, or anticonvulsants (see Chapter 14). Used patches must be disposed of securely because they may be dangerous to children or pets. Specific pharmacokinetic data are not listed due to the continuous nature of dosing. Studies have demonstrated that a patch can provide varying degrees of pain relief for 4 to 12 hours. Nursing Process Pain may be acute or chronic and occurs in patients in all settings and across the lifespan, thus leading to much suffering and distress. Patients experiencing pain pose many challenges to the nurse, prescribers, and other members of the health care team involved in their care. The challenge is that pain is a complex and multifaceted problem and demands astute assessment skills with appropriate interventions based on the individual, the specific type of pain, related diseases, and/or health status. Medical associations, health care organizations, governing bodies, and professional nursing organizations have been involved in defining standards and outcomes of care related to assessment and management of pain. For example, The Joint Commission (www.jointcommission.org) and the Agency for Healthcare Research and Quality (www.ahrq.gov/whatsnew.asp#qt) have developed such standards. In addition, the WHO (www.who.int/en) has developed standards related specifically to cancer pain. Professional nursing organizations, such as the Oncology Nursing Society and the American Nurses Association, have also created standards of care related to pain assessment and management. In 2009, the American Pain Society published guidelines for opioid therapy in chronic noncancer pain. (See www.americanpainsociety.org for more guidelines and their detailed report.) Assessment Adequate analgesia requires a holistic, comprehensive, and individualized patient assessment with specific attention to the 579 comfort. Comfort, in this situation, is defined as the extent of physical and psychologic ease that an individual experiences. Perform a thorough health history, nursing assessment, and medication history as soon as possible or upon the first encounter with the patient, including questions about the following: (1) allergies to nonopioids, opioids, partial or mixed agonists, and/or opioid antagonists (see previous pharmacologic discussion for examples of specific drugs); (2) potential drug-drug and/or drugfood interactions; (3) presence of diseases or CNS depression; (4) history of the use of alcohol, street drugs, or any illegal drug or substance and/or history of substance abuse, with information about the substance, dose, and frequency of use; (5) results of laboratory tests ordered, such as levels of serum ALT, ALP, GGT, 5′-nucleotidase, and bilirubin (indicative of liver function), and/or levels of BUN and creatinine (reflective of renal function); abnormal liver or renal function may require that lower doses of analgesic be used to prevent toxicity or overdosage (see the box “Safety: Laboratory Values related to Drug Therapy”); (6) character and intensity of the pain, including onset, location, and quality (e.g., stabbing/knifelike, throbbing, dull ache, sharp, diffuse, localized, or referred); actual rating of the pain using a pain assessment scale (see later); and any precipitating, aggravating, and/or relieving factors; (7) duration of the pain (acute vs. chronic); and (8) types of pharmacologic, nonpharmacologic, and/or adjunctive measures that have been implemented, with further explanation of the treatment's duration of use and overall effectiveness. To be thorough and effective, include in your assessment the factors or variables that may impact an individual's pain experience, such as physical factors (e.g., age, gender, pain threshold, overall state of health, disease processes, or pathologies) and emotional, spiritual, and cultural variables (e.g., reaction to pain, pain tolerance, fear, anxiety, stressors, sleep patterns, societal influences, family roles, phase of growth and development, and religious, racial, and/or ethnic beliefs or practices). Age-appropriate assessment tools are recommended in assessing pain across the lifespan (see later discussion). For pediatric and older adult patients, nonverbal behavior or cues and information from family members or caregivers may be helpful in identifying pain levels. In 580 members or caregivers may be helpful in identifying pain levels. In an older adult individual, physical and cognitive impairments may affect reporting of pain; however, this does not mean that the older adult patient is not experiencing pain—the patient's reporting may just be altered. Chronic pain and pain associated with cancer are both complex and multifactorial problems requiring a holistic approach with attention to other patient complaints, such as a decrease in activities of daily living, insomnia, depression, social withdrawal, anxiety, personality changes, and quality of life issues. Perform a system-focused nursing assessment with collection of both subjective and objective data as follows: neurologic status (e.g., level of orientation and alertness, level of sedation, sensory and motor abilities, reflexes); respiratory status (e.g., respiratory rate, rhythm, and depth; breath sounds); GI status (e.g., presence of bowel sounds; bowel patterns; complaints of constipation, diarrhea, nausea, vomiting, or abdominal discomfort); genitourinary status (e.g., urinary output, any burning or discomfort on urination, urinary retention); and cardiac status (e.g., pulse rate and rhythm, blood pressure, any problems with dizziness or syncope). Assess and document vital signs, including blood pressure, pulse rate, respirations, temperature, and level of pain (now considered the fifth vital sign). It is important to pull from one's knowledge base and remember that during the acute pain response, stimulation of the sympathetic nervous system may result in elevated values for vital signs, with an increase in blood pressure (120/80 mm Hg or higher), pulse rate (100 beats/min or higher), and respiratory rate and depth (20 breaths/min or higher and shallow breathing). Patient-Centered Care: Lifespan Considerations for the Pediatric Patient Opioid Use • Assessment of the pediatric patient is challenging, and all types of behavior that may indicate pain, such as muscular rigidity, restlessness, screaming, fear of moving, and 581 • Adequacy of pain management is more difficult to determine in children because of their inability to express themselves. Frequently the reason older pediatric patients do not verbalize their pain is their fear of treatment, such as injections. Compassionate and therapeutic communication skills, as well as the use of alternate routes of administration, as ordered, will help in these situations. • The “ouch scale” is often used to determine the level of pain in children. This scale is used to obtain the child's rating of the intensity of pain from 0 to 5 by means of simple face diagrams, from a very happy face for level 0 (no pain) to a sad, tearful face for level 5 (severe pain). Pain assessment is very important in pediatric patients because they are often undermedicated. Always thoroughly assess the pediatric patient's verbal and nonverbal behavior, and never underestimate the patient's complaints! Remember that parents and caregivers can play a very important role in this assessment. • The patient's baseline age, weight, and height are important to document, because drug calculations are often based on these variables. With the pediatric patient, check and double-check all mathematical calculations for accuracy to avoid excessive dosages; this is especially true for opioids. • Analgesics must be given, as ordered, before pain becomes severe, with oral dosage forms used first, if appropriate. • If suppositories are used, be careful to administer the exact dose and not to split, halve, or divide an adult dose into a child's dose. This may result in the administration of an unknown amount of medication and possible overdose. • When subcutaneous, intramuscular, and intravenous medications are used, the principle of atraumatic care in the delivery of nursing care must be followed. One technique used to help ensure atraumatic care is the application of a mixture of local anesthetics or other prescribed substances to the injection site before the injection is given. EMLA (lidocaine/prilocaine) is a topical cream that anesthetizes the site of the injection; if ordered, apply 1 to hours before the injection. Consult policies and procedures for further instructions regarding its 582 policies and procedures for further instructions regarding its use. • Distraction and creative imagery may be used for older children such as toddlers or preschool-age children. • Always monitor pediatric patients very closely for any unusual behavior while receiving opioids. • Report the following signs and symptoms of central nervous system changes to the prescriber immediately if they occur: dizziness, lightheadedness, drowsiness, hallucinations, changes in level of consciousness, and sluggish pupil reaction. Do not administer further medication until the nurse receives further orders from the prescriber. • Always monitor and document vital signs before, during, and after the administration of opioid analgesics. An opioid medication is usually withheld if a patient's respirations are less than 12 breaths/min or if there are any changes in the level of consciousness. Always follow protocol, and never ignore a patient's status! • Generally speaking, smaller doses of opioids, with very close and frequent monitoring, are indicated for the pediatric patient. Giving oral medications with meals or snacks may help to decrease gastrointestinal upset. A variety of pain assessment tools are available that may be used to gather information about the fifth vital sign. One very basic assessment tool is the Numeric Pain Intensity Scale (0 to 10 pain rating scale); patients are asked to rate their pain intensity by picking the number that most closely represents their level of pain. The Verbal Rating Scale, another pain assessment tool, uses verbal descriptors for pain, including words such as mild, moderate, severe, aching, agonizing, or discomfort. The FACES Pain Rating Scale is helpful in assessing pain in patients of all ages and educational levels because it relies on a series of faces ranging from happy to sad to sad with tears. The patient is asked to identify the face that best represents the pain he or she is experiencing at that moment. When the patient is in acute pain, when pain intensity is a primary focus for assessment, and/or when the need is to determine the 583 dimensional scales (e.g., the Numeric Pain Intensity Scale) work best. The FLACC (Face, Legs, Activity, Cry, Consolability) pain assessment scale may be used in children who are nonverbal but could also be used in any age of patient who is experiencing trauma or nonverbal. Zero, one, or two points are assigned to the five categories of Face, Legs, Activity, Cry, and Consolability. Further information is available at www.nhpco.org/flacc-scores. The older adult, especially those with cognitive impairment, may need more time to respond to the assessment tool and may also require largeprint versions of written tools. There are other assessment tools that are multidimensional scales and are more beneficial in assessing patients who experience chronic rather than acute pain. One example is the Brief Pain Inventory assessment tool, which includes a body map so that the patient can identify on the figure the exact area where pain is felt. This tool also helps in obtaining information about the impact of pain on functioning. Assess pain before, during, and after the pain intervention, as well as the level of pain during activity and at rest. The following sections provide assessment information for specific drug classes. Nonopioids For patients receiving nonopioid analgesics, focus the assessment not only on general data as described earlier but also on the specific drug being given. For example, in those patients taking acetaminophen, begin the assessment by determining whether the patient has allergies, is pregnant, and/or is breastfeeding. As mentioned in the pharmacology section, acetaminophen is contraindicated in those with severe liver disease and in patients with G6PD deficiency. Additionally, cautious use is necessary due to possible adverse effects of blood disorders (anemias) and liver or kidney toxicity. See the pharmacology discussion for more information about acute overdose and chronic unintentional misuse. Also assess for any other medications the patient is taking, because of the risk for excessive doses when taking combination products consisting of acetaminophen. Inadvertent overdosing is a possible consequence of this situation. Other drug interactions and concerns are addressed in the pharmacology discussion. Once therapy has been initiated, closely monitor for chronic 584 Once therapy has been initiated, closely monitor for chronic acetaminophen poisoning, looking for symptoms such as rapid, weak pulse, dyspnea, and cold and clammy extremities. Long-term daily use of acetaminophen may lead to increased risk for permanent liver damage, and therefore you must frequently monitor the results of liver function studies. Adults who ingest higher than recommended dosages may be at higher risk for liver dysfunction as well as other adverse effects such as loss of appetite, jaundice, nausea, and vomiting. Children are also at high risk for liver dysfunction if the recommended dosage ranges are exceeded. With the use of NSAIDs (e.g., ibuprofen, aspirin, COX-2 inhibitors), assess kidney and liver functioning and gather information about GI disorders such as ulcers (see Chapter 44 for more information on antiinflammatory drugs). With aspirin, age is important; this drug is not to be given to children and adolescent patients because of the risk of Reye's syndrome. Aspirin may also lead to bleeding and ulcers, so ruling out conditions that represent contraindications and cautions to its use before therapy begins is important to patient safety. With tramadol hydrochloride, assessment of age is important because this drug is not recommended for use in individuals 75 years of age or older. A miscellaneous nonopioid analgesic, lidocaine transdermal, is another option for managing different types of pain. For lidocaine transdermal patches, understand that this transdermal drug is indicated in those with postherpetic neuralgia, and thus assess the herpetic lesion(s) and surrounding skin. When these patches are used, they must be kept away from children and are not to be prescribed for very young, small, or debilitated patients because these patients are at higher risk for toxicity. Liver function also needs to be assessed and monitored. Opioids When opioid analgesics, or any other CNS depressants, are prescribed, focus assessment on vital signs; allergies; respiratory disorders; respiratory function (rate, rhythm, depth, and breath sounds); presence of head injury (which will mask signs and symptoms of increasing intracranial pressure); neurologic status, with attention to level of consciousness or alertness and the level of 585 (bowel sounds and bowel patterns); and genitourinary functioning (intake and output). In addition, all opioids may cause spasms of the sphincter of Oddi. If renal and liver function studies are ordered, monitor results, because the risk for toxicity increases with diminished function of these organs. An additional concern is any past or present history of neurologic disorders such as Alzheimer's disease, dementia, multiple sclerosis, muscular dystrophy, myasthenia gravis, or cerebrovascular accident or stroke, because the use of opioids may alter symptoms of the disease process, possibly masking symptoms or worsening the clinical presentation when no actual pathologic changes have occurred. In these situations, use of another analgesic or pain protocol may be indicated. Attention to age is also important, because both older adult and very young patients are more sensitive to opioids—and holds true for many other medications. In fact, old or young age may be a contraindication to opioid use, depending on the specific drug. See earlier pharmacology discussion regarding cautions, contraindications, and drug interactions. Opioid Agonists-Antagonists In patients taking opioid agonists-antagonists, such as buprenorphine hydrochloride, assess vital signs with attention to respiratory rate and breath sounds. The opioid agonists-antagonists still possess opioid agonist effects; therefore, the assessment information related to opioids is applicable to these drugs as well. It is also very important to remember during assessment that these drugs are still effective analgesics and still have CNS depressant effects but are subject to a ceiling effect (see earlier definition). Given the action of these drugs, the assessment may help determine whether the patient is an abuser of opioids. This is important because the simultaneous administration of agonists-antagonists with another opioid will lead to reversal of analgesia and possible opioid withdrawal. Age is another factor to assess, because these drugs are not recommended for use in patients 18 years of age or younger. See the previous discussion for a listing of contraindications, cautions, and drug interactions. Opioid Antagonists 586 Opioid Antagonists Remember that the opioid antagonists are used mainly in reversing respiratory depression secondary to opioid overdosage. Naloxone may be used in patients of all ages, including neonates and children. Assess and document vital signs before, during, and after the use of the antagonist so that the therapeutic effects can be further assessed and documented and the need for further doses determined. In addition, remember that the antagonist drug may not work with just one dosing and that repeated doses are generally needed to reverse the effects of the opioid. See the pharmacology section for information about contraindications, cautions, and drug interactions. Human Need Statements 1. Altered oxygenation, decreased, related to opioid-induced CNS effects and respiratory depression 2. Freedom from pain, acute, related to specific disease processes or conditions and other pathologies leading to various levels and types of pain 3. Freedom from pain, chronic, related to various disease processes, conditions, or syndromes causing pain 4. Altered gastrointestinal elimination, constipation, related to the CNS depressant effects on the GI system 5. Decreased self-determination related to deficient knowledge and lack of familiarity with opioids, their use, and their adverse effects Planning: Outcome Identification 1. Patient regains/maintains a respiratory rate between 10 and 20 breaths/min without respiratory depression while increasing fluid intake and coughing/deep breathing while taking opioids and/or other analgesics for pain. 2. Patient relates increased comfort levels from acute as seen by decreased use of analgesics, increased activity and performance of activities of daily living, decreased 587 as rated on a scale of 1 to 10 or alternative pain scales. 3. Patient states increased comfort and decrease in chronic pain levels as seen by decreased use of analgesics, increased use of nonpharmacologic pain relief measures and a notable increase in performance of activities of daily living and decrease in the rating of pain. 4. Patient identifies measures to help maintain normal bowel elimination patterns and avoids/minimizes opioid-induced constipation by increasing fluids and fiber in the diet and increasing mobility. 5. Patient reports appropriate use of analgesics with minimal complications/adverse effects and is able to state the drug's rationale, action, and therapeutic effects. Implementation Once the cause of pain has been diagnosed or other assessment and data gathering have been completed, begin pain management immediately and aggressively in conformity with the needs of each individual patient and situation. Pain management is varied and multifaceted and needs to incorporate pharmacologic as well as nonpharmacologic approaches (see Box 10.1 and the box Safety: Herbal Therapies and Dietary Supplements on the next page). Pain management strategies must also include consideration of the type of pain and pain rating as well as pain quality, duration, and precipitating factors, and interventions that help the pain. Some general principles of pain management are as follows: (1) Individualize a plan of care based on the patient as a holistic and cultural being (see the box Patient-Centered Care: Cultural Implications on p. 137). (2) Manage mild pain with the use of nonopioid drugs such as acetaminophen, tramadol, and NSAIDs (see Chapter 44). (3) Manage moderate to severe pain with a stepped approach using opioids. Other analgesics or types of analgesics may be used in addition to other categories of medication (see pharmacology discussion). (4) Administer analgesics as ordered but before the pain gets out of control. (5) Always consider the use of nonpharmacologic comfort measures (see Box 10.1) such as ice, heat, elevation, rest, homeopathic and 588 (see Box 10.1) such as ice, heat, elevation, rest, homeopathic and folk remedies, exercise, distraction, music or pet therapy, massage, and transcutaneous electrical stimulation. Although not always effective, these measures may prove beneficial for some patients. See the box “Patient-Centered Care: Patient Teaching” on p. 162 for more information related to analgesics. Safety: Herbal Therapies and Dietary Supplements Feverfew (Chrysanthemum parthenium) Overview A member of the marigold family known for its antiinflammatory properties Common Uses Treatment of migraine headaches, menstrual cramps, inflammation, and fever Adverse Effects Nausea, vomiting, constipation, diarrhea, altered taste sensations, muscle stiffness, and joint pain Potential Drug Interactions Possible increase in bleeding with the use of aspirin and other nonsteroidal antiinflammatory drugs, dipyridamole, and warfarin Contraindications Contraindicated in those allergic to ragweed, chrysanthemums, and marigolds, as well as those about to undergo surgery Nonopioids Give nonopioid analgesics as ordered or as indicated for fever or pain. Acetaminophen is to be taken as prescribed and within the recommended dosage range over a 24-hour period because of the risk for liver damage and acute toxicity. If a patient is taking other 589 and/or flu medications), he or she needs to understand the importance of reading the labels very carefully (of other medications) to identify the total amount of acetaminophen taken and any other drug-drug interactions. In educating the patient, emphasize the signs and symptoms of acetaminophen overdose: bleeding, loss of energy, fever, sore throat, and easy bruising (due to hepatotoxicity). These must be reported immediately by the patient, family member, or caregiver to the nurse and/or prescriber. Any worsening or changing in the nature and/or characteristic of pain must also be reported. Suppository dosage forms of acetaminophen—like suppository forms of other drugs—may be placed into a medicine cup of ice to prevent melting of the dosage form. Once the suppository is unwrapped, cold water may be run over it to moisten the suppository for easier insertion. The suppository is inserted into the rectum using a gloved finger and water-soluble lubricating gel, if necessary. Acetaminophen tablets may be crushed, if needed, but not the gel or capsule dosage form. The maximum dosage recommended for adults with alcoholism is not to exceed 2 g/day because of the risk for hepatotoxicity. Death may occur after ingestion of more than 15 g. Liver damage from acetaminophen may be minimized by timely dosing with acetylcysteine (see previous discussion). If acetylcysteine is indicated, warn the patient about the drug's foul taste and odor. Many patients report that the drug smells and tastes like rotten eggs. Acetylcysteine is better tolerated if it is disguised by mixing with a drink such as cola or flavored water to increase its palatability. Use of a straw may help minimize contact with the mucous membranes of the mouth and is recommended. This antidote may be given through a nasogastric or orogastric tube or intravenously, if necessary. If a patient is receiving acetaminophen or taking it at home and has also been prescribed hydrocodone (Vicodin, Norco) or oxycodone (Percocet, Tylox), there is danger of overdosage with the acetaminophen. This overdosage may occur if the patient is not aware of the fact that acetaminophen is in the prescribed medication. Hepatotoxicity would be of concern, so it is critical to patient safety to educate about the ingredients of over-the-counter medications as well as prescribed medications. As discussed in the 590 medications as well as prescribed medications. As discussed in the pharmacology section, the FDA announced that combination products are to be limited to 325 mg of acetaminophen, and they currently limit total daily doses to 4000 mg. Patients with liver disease or chronic alcohol consumption are advised not to exceed 2000 mg/day. Tramadol may cause drowsiness, dizziness, headache, nausea, constipation, and respiratory depression. If dizziness, blurred vision, or drowsiness occur, be sure to assist the patient with ambulation (as with the use of any analgesic that may lead to dizziness or lightheadedness) to minimize the risk for fall and injury. Educate the patient about injury prevention, including the need to dangle the feet over the edge of the bed before full ambulation, changing positions slowly, and asking for assistance when ambulating. In addition, while the patient is taking tramadol —as well as any other analgesics, and especially opioids—the patient needs to avoid any tasks that require mental clarity and alertness. Increasing fluids and fiber in the diet may help with constipation. Use of flat cola, ginger ale, or dry crackers may help to minimize nausea. Opioids When opioids (and other analgesics) are prescribed, administer the drug as ordered after checking for the “Nine Rights” of medication administration (see Chapter 1). After the prescriber's order has been double-checked, closely examine the medication profile and documentation to determine the last time the medication was given before another dose is administered. Monitor the patient's vital signs at frequent intervals with special attention to respiratory changes. A respiratory rate of 10 breaths/min (some protocols still adhere to the parameter of 12 breaths/min) may indicate respiratory depression and must be reported to the prescriber. The drug dosage, frequency, and/or route may need to be changed or an antidote (opioid antagonist) given if respiratory depression occurs. Naloxone must always be available, especially with the use of intravenous and/or other parenteral dosage forms of opioids, such as PCA (see Chapter 9 and the discussion to follow), and/or epidural infusions. Naloxone is indicated to reverse CNS 591 this antidote also reverses analgesia. Monitor urinary output. In the adult patient, urinary output is between 800 and 2000 ml/day (at least 33.3 to 83.3 per hour). Monitor bowel sounds during therapy; decreased peristalsis may indicate the need for a dietary change, such as increased fiber, or use of a stool softener or mild laxative (see the box “Safety and Quality Improvement: Identifying Potential Opioid Adverse Effects”). Assess the patient's pupillary reaction to light. Pinpoint pupils indicate a possible overdose. It is crucial to patient safety to re-emphasize the importance of understanding equianalgesia. For example, hydromorphone (Dilaudid) is seven times more potent than morphine. Deaths have been reported where a nurse gave the patient morphine and did not realize the equianalgesic equivalency (see previous discussion in the pharmacology section). Opioids or any analgesic must be given before the pain reaches its peak to help maximize the effectiveness of the opioid or other analgesic. Once the drug is administered, return at the appropriate time (taking into consideration the times of onset and peak effect of the drug and the route) to assess the effectiveness of the drug and/or other interventions as well as observe for the presence of adverse effects (see previous discussion of pain assessment tools). With regard to the route of administration, the recommendation is that oral dosage forms be used first, but only if ordered and if there is no nausea or vomiting. Taking the dose with food may help minimize GI upset. Should nausea or vomiting be problematic, an antiemetic may be ordered for administration before or with the dosing of medication. Crucial safety measures include keeping the bed's side rails up, turning on bed alarms (depending on the policies and procedures of the specific health care institution), and making sure the call bell/alarm is within the patient's reach. These measures will help to prevent falls or injury related to opioid use. Opioids and similar drugs lead to CNS depression with possible confusion, altered sensorium or alertness, hypotension, and altered motor functioning. Because of these drug effects, all patients are at risk for falls or injury, and the older adult is at higher risk (see the boxes “Safety and Quality Improvement: Identifying Potential Opioid Adverse Effects” and “Patient-Centered Care: Lifespan Considerations for the Older Adult Patient”). See Box 10.3 for more 592 Considerations for the Older Adult Patient”). See Box 10.3 for more specific information concerning the handling of controlled substances and opioid counts. Box 10.3 Controlled Substance/Opioid Counts—A Must-Do! Any medication that has the potential for abuse or is a controlled substance—often opioids—is handled differently from other medications. Opioids are delivered to a nursing unit by the pharmacy, and these and other controlled substances (see Chapter 4) are kept in a locked cabinet or in an automated dispensing system (see Chapter 9). At the beginning of each shift, two registered nurses must count all of the opioids and/or other controlled substances located in the locked cabinet and record the count on a controlled substance and/or opioid administration record. When opioids and other controlled substances are dispensed through an automated medication-dispensing system, the drug is counted before the nurse removes the dose from the system. Any discrepancies found in the count of opioids or other controlled substances are investigated by registered nurses. If any opioids are unaccounted for, the nurse manager or supervisor needs to be contacted immediately. The following guidelines must be adhered to when giving opioids and other controlled substances: (1) Check the opioid administration record for the number left in stock. (2) Compare this number with the actual supply available. (3) If the count is accurate, obtain the desired dose of drug. (4) If the count is incorrect, notify the nurse manager or supervisor and follow the health care setting's policies and procedures. (5) Record the count of the remaining supply. Once the dose is removed, the nurse may be required to record the patient's name, prescriber's name, patient's medical record number, dose of medication ordered, and the nurse's signature. (6) Administer the drug according to policy and procedures. If the controlled substance cannot be given to the patient because of patient refusal, medication contamination, changes in vital signs or status, or some 593 wasting of controlled substances requires the signature of another nurse who witnesses the discarding or wasting of the medication and documentation on the appropriate form. Automated systems record this information within the computer system. When managing pain with morphine and similar drugs, withhold the dose and contact the prescriber if there is any decline in the patient's condition or if the vital signs are abnormal (see parameters mentioned earlier), especially if the respiratory rate is less than 10 breaths/min. Intramuscular injections are rarely used because of the availability of other effective and convenient dosage forms, such as PCA pumps, transdermal patches, continuous subcutaneous infusions, and epidural infusions. Patient-Centered Care: Lifespan Considerations for the Older Adult Patient Opioid Use • Record the patient's weight and height before opioid therapy is begun, if appropriate. Monitor the patient carefully for any changes in vital signs, level of consciousness, or respiratory rate, as well as any changes indicative of central nervous system (CNS) depression, and report and document any such changes. • Many institutionalized or hospitalized older adult patients are very stoic about pain; older adult patients may also have altered presentations of common illnesses so that the pain experience manifests in a different way or may simply be unable to state how they feel in a clear manner. Each and every patient—regardless of age—has the right to a thorough pain assessment and adequate and appropriate pain management. It is a myth that aging increases one's pain threshold. The problem is that cognitive impairment and dementia are often major barriers to pain assessment. Nevertheless, many older adult patients are still reliable in their reporting of pain, even 594 adult patients are still reliable in their reporting of pain, even with moderate to severe cognitive impairment. • Over time, the older adult patient may lose reliability in recalling and accurately reporting chronic pain. The older adult patient, especially those 75 years of age or older, are at higher risk for too much or too little pain management, so you must remember that drugs have a higher peak and longer duration of action in these patients than in their younger counterparts. • Smaller dosages of opioids are generally indicated for older adult patients because of their increased sensitivity to the CNS depressants and diminished renal and hepatic function. Paradoxical (opposite) reactions and/or unexpected reactions may also be more likely to occur in patients of this age group. • In older adult male patients, benign prostatic hyperplasia or obstructive urinary diseases must be considered because of the urinary retention associated with the use of opioids. Urinary outflow can become further diminished in these patients and result in adverse reactions or complications. Dosage adjustments may need to be made by the prescriber. • Polypharmacy is often a problem in older adults; therefore have a complete list of all medications the patient is currently taking, and assess for drug interactions and treatment (drug) duplication. • Frequent assessment of older adult patients is needed. Pay attention to level of consciousness, alertness, and cognitive ability while ensuring that the environment is safe by keeping a call bell or light at the bedside. Using bed alarms and/or raising side rails are indicated when appropriate. • Decreased circulation causes variation in the absorption of intramuscular or intravenous dosage forms and often results in the slower absorption of parenteral forms of opioids. • As stated by the American Geriatric Society on the Management of Pain, nonsteroidal antiinflammatory drugs must be used with caution because of their potential for renal and gastrointestinal toxicity. Acetaminophen is the drug of choice for relieving mild to moderate pain, but with cautious 595 administration is preferred for analgesia. The regimen needs to be as simple as possible to enhance compliance. Be sure to note, report, and document any unusual reactions to the opioid drugs. Hypotension and respiratory depression may occur more frequently in older adult patients taking opioids; thus very careful vital sign monitoring is needed. For transdermal patches (e.g., transdermal fentanyl), two systems are used. The oldest type of patch contains a reservoir system consisting of four layers beginning with the adhesive layer and ending with the protective backing. Between these two layers are the permeable rate-controlling membrane and the reservoir layer, which holds the drug in a gel or liquid form. The newer type of patch has a matrix system consisting of two layers: one layer containing the active drug with the releasing and adhesive mechanisms, and the protective impermeable backing layer. The advantages of the matrix system over the reservoir system are that the patch is slimmer and smaller, it is more comfortable, it is worn for up to 7 days (the older reservoir system patch is worn for up to 3 to 4 days), and it appears to result in more constant serum drug levels. In addition, the matrix system is alcohol-free; the alcohol in the reservoir system often irritates the patient's skin. It is important to know what type of delivery system is being used so that proper guidelines are followed to enhance the system's and drug's effectiveness. Apply transdermal patches to only a clean, nonhairy area. When the patch is changed, place the new patch on a new site, but only after the old patch has been removed and the old site cleansed of any residual medication. Rotation of sites helps to decrease irritation and enhance drug effects. Transdermal patches require special discarding of old/used patches (see the box Safety and Quality Improvement: Preventing Medication Errors on p. 145). Transdermal systems are beneficial for the delivery of many types of medications, especially analgesics, and have the benefits of allowing multiday therapy with a single application, avoiding firstpass metabolism, improving patient compliance, and minimizing frequent dosing. However, the patient must be watched carefully for the development of any type of contact dermatitis caused by the 596 for the development of any type of contact dermatitis caused by the patch (the prescriber is to be contacted immediately if this occurs) and maintain his or her own pain journal when at home. Journal entries are a valid source of information for the nurse, other health care professionals, the patient, and family members to assess the patient's pain control and to monitor the effectiveness not only of transdermal analgesia but also any medication regimen. With the intravenous administration of opioid agonists, follow manufacturer guidelines and health care institution policy regarding specific dilutional amounts and solutions as well as the time period for infusion. When PCA is used, the amounts and times of dosing must be noted in the appropriate records and tracked by appropriate personnel. The fact that a pump is being used, however, does not mean that it is 100% reliable or safe. Closely monitor and frequently check all equipment. Additionally, frequently monitor pain levels, response to medication, and vital signs with the use of other parenteral opioid administration. Always follow dosage ranges for all opioid agonists, and pay special attention to the dosages of morphine and morphine-like drugs. For intravenous infusions, you are responsible for monitoring the intravenous needle site and infusion rates and documenting any adverse effects or complications. Another point to remember when administering opioids—as well as any other analgesic—is that each medication has a different onset of action, peak, and duration of action, with the intravenous route producing the most rapid onset (e.g., within minutes). To reverse an opioid overdose or opioid-induced respiratory depression, an opioid antagonist, such as naloxone, must be administered. Naloxone is given intravenously in diluted form and administered slowly (such as over 15 seconds, or as ordered; Table 10.7). However, consider the packaging and manufacturer guidelines. Emergency resuscitative equipment must always be available in the event of respiratory or cardiac arrest. TABLE 10.7 Opioid Administration Guidelines Opioid Nursing Administration 597 and butorphanol codeine min). Always assess respirations before, during, and after use. Give IM as ordered. Give PO doses with food to minimize GI tract upset; ceiling effects occur with oral codeine resulting in no increase in analgesia with increased dosage. fentanyl Administer parenteral doses over 1–2 min as ordered and as per manufacturer guidelines in regard to mg/min to prevent CNS depression and possible cardiac or respiratory arrest. Transdermal patches come in a variety of dosages. Fentanyl lozenges on a stick are also available. Be sure to remove residual amounts of the old patch before application of a new patch. Dispose of patches properly to avoid inadvertent contact with children or pets. Patches are to be folded and flushed down the toilet. hydromorphone May be given sub-q, rectally, IV, PO, or IM. meperidine Given by a variety of routes: IV, IM, or PO; highly protein bound, so watch for interactions and toxicity. Monitor older adult patients for increased sensitivity. morphine Available in a variety of forms: subQ, IM, PO, IV, extended- and immediate-release; morphine sulfate (Duramorph) for epidural infusion. Always monitor respiratory rate. nalbuphine IV doses of 10 mg given undiluted over 5 min. naloxone Antagonist given for opioid overdose; 0.4 mg usually given IV over 15 sec or less. Reverses analgesia as well. oxycodone Often mixed with acetaminophen or aspirin; PO and suppository dosage forms. Now available in both immediate and sustainedrelease tablets. CNS, Central nervous system; GI, gastrointestinal. Opioid Agonists-Antagonists Remember when giving agonists-antagonists that they react very differently depending on whether they are given by themselves or with other drugs. When administered alone, they are effective analgesics because they bind with opiate receptors and produce an agonist effect (see discussion in the pharmacology section). If given at the same time as other opioids, however, they lead to reversal of analgesia and acute withdrawal because of the blocking of opiate receptors. Be very careful to check dosages and routes as well as to perform the interventions mentioned for opioid agonist drugs, including closely assessing vital signs, especially respiratory rate. Emphasize the importance of reporting any dizziness, unresolved constipation, urinary retention, and sedation. Other points to 598 emphasize with the patient include that the drug also has the ability to reverse analgesia as well as precipitate withdrawal (if taken with other opioid agonists). A list of other opioid agonists must be shared with the patient, as well. Opioid Antagonist Opioid antagonist must be given as ordered and be readily available, especially when the patient is receiving PCA with an opioid, is opioid naive, or is receiving continuous doses of opioids. Several doses of these drugs are often required to ensure adequate opioid agonist reversal (see earlier discussion). Encourage patients to report any nausea or tachycardia. General Considerations You are always responsible and accountable to maintain a current, updated knowledge base on all forms of analgesics as well as protocols for pain management with focus on the specific drug(s) as well as differences in the treatment of mild to moderate pain, severe pain, and pain in special situations (e.g., cancer pain). The WHO's three-step analgesic ladder provides a standard for pain management in cancer patients and must be reviewed and considered, as needed. Dosing of medications for pain management is very important to the treatment regimen. As noted earlier, once a thorough assessment has been performed, it is best to treat the patient's pain before it becomes severe, which is the rationale for considering pain to be the fifth vital sign. When pain is present for more than 12 hours a day, analgesic doses are individualized and are best administered around the clock rather than on an as-needed basis, while always staying within safe practice guidelines for each drug used. Around-the-clock (or scheduled) dosing maintains steadystate levels of the medication and prevents drug troughs and pain escalation. No given dosage of an analgesic will provide the same level of pain relief for every patient; thus there is a need for a process of titration—upward or even downward—to be carried out based on the individual's needs. Aggressive titration may be necessary in difficult pain control cases and in cancer pain situations. Patients with severe pain, metastatic pain, or bone 599 metastasis pain may need increasingly higher dosages of analgesic. These special pain situations may require an opiate such as morphine that needs to be titrated until the desired response is achieved or until adverse effects occur. A patient-rated pain level of less than 4 on a scale of 1 to 10 is considered to indicate effective pain relief. However, this may vary depending on the health care provider, health care setting, and/or unit. If pain is not managed adequately by monotherapy, other drugs or adjuvants may need to be added to enhance analgesic efficacy. This includes the use of NSAIDs (for analgesic, antiinflammatory effects), acetaminophen (for analgesic effects), corticosteroids (for mood elevation and antiinflammatory, antiemetic, and appetite stimulation effects), anticonvulsants (for treatment of neuropathic pain), tricyclic antidepressants (for treatment of neuropathic pain and for their innate analgesic properties and opioid-potentiating effects), neuroleptics (for treatment of chronic pain syndromes), local anesthetics (for treatment of neuropathic pain), hydroxyzine (for mild antianxiety properties as well as sedating effects and antihistamine and mild antiemetic actions), or psychostimulants (for reduction of opioid-induced sedation when opioid dosage adjustment is not effective). Table 10.8 provides a listing of drugs that are not to be used in patients experiencing cancer pain. TABLE 10.8 Drugs Not Recommended for Treatment of Cancer Pain Class Opioids with short durations of action Miscellaneous Drug Meperidine Cannabinoids Opioid agonists- Pentazocine, antagonists butorphanol, nalbuphine buprenorphine Reason for Not Recommending Short (2–3 h) duration of analgesia; administration may lead to CNS toxicity (tremor, confusion, or seizures) Adverse effects of dysphoria, drowsiness, hypotension, and bradycardia; may be indicated for use in treating severe chemotherapy-induced nausea and vomiting May precipitate withdrawal in opioiddependent patients; analgesic ceiling effect; possible production of unpleasant psychologic adverse effects, including dysphoria, delusions, and hallucinations Analgesic ceiling effect; can precipitate 600 withdrawal if given with an opioid Reverses analgesia as well as CNS depressant effects, such as respiratory depression Combination Brompton cocktails No evidence of analgesic benefit over use preparations of a single opioid analgesic a DPT (meperidine, Efficacy poor compared with that of other analgesics; associated with a higher promethazine, and incidence of adverse effects chlorpromazine) Anxiolytics (as Benzodiazepines Analgesic properties not associated monotherapy) or (e.g., with these drugs. Risk for sedation, sedativesalprazolam) which may put some patients at hypnotics (as Barbiturates higher risk for neurologic monotherapy) complications Analgesic properties not demonstrated; sedation is problematic and limits use Opioid antagonists naloxone a DPT is the abbreviation for the trade names Demerol, Phenergan, and Thorazine. CNS, Central nervous system. Dosage forms are also important, especially with chronic pain and cancer pain. Oral administration is always preferred but is not always tolerated by the patient and may not even be a viable option for pain control. If oral dosing is not appropriate, less invasive routes of administration include rectal and transdermal routes. Rectal dosage forms are safe, inexpensive, effective, and helpful if the patient is experiencing nausea or vomiting or altered mental status; however, this route is not suitable for those with diarrhea, stomatitis, and/or low white blood cell counts. Transdermal patches may provide up to 7 days of pain control but are not for rapid dose titration and are used only when stable analgesia has been previously achieved. Long-acting forms of morphine and fentanyl may be delivered via transdermal patches when a longer duration of action is needed. Intermittent injections or continuous infusions via the intravenous or subcutaneous route are often used for opioid delivery and may be administered at home in special pain situations, such as in hospice care or management of chronic cancer pain. Subcutaneous infusions are often used when there is no intravenous access. PCA pumps may be used to help deliver opioids intravenously, subcutaneously, or even intraspinally and can be managed in home health care or hospice care for the patient 601 at home. Use of the intrathecal or epidural route requires special skill and expertise, and delivery of pain medications using these routes is available only from certain home health care agencies for at-home care. The main reason for long-term intraspinal opioid administration is intractable pain. Transnasal dosage forms are approved only for butorphanol, an agonist-antagonist drug, and this dosage form is generally not used or recommended. Regardless of the specific drug or dosage form used, a fast-acting rescue drug needs to be ordered and available for patients with cancer pain and patients presenting other special challenges in pain management. Case Study Safety: What Went Wrong? Opioid Administration © Gpalmer. You are the home health nurse assigned to care for a patient who is in the terminal phases of breast cancer. Mrs. D. is 48 years of age and underwent bilateral mastectomy 4 years ago. She had lymph node involvement at the time of surgery, and recently has been diagnosed with metastasis to the bone. She has been taking one 5mg tablet of oxycodone every 4 to 6 hours for pain as needed. She is not sleeping through the night and is now complaining of increasing pain to the point that her quality of life has decreased significantly. She wants to stay at home during the terminal phases of her illness but needs to have adequate and safe pain control. Her husband of 18 years is very supportive. They have no children. 602 They are both college graduates and have medical insurance. 1. Mrs. D.'s recent increase in pain has been attributed to bone metastasis in the area of the lumbar spine. At this time, the oxycodone is not beneficial, and you as the home health care nurse need to advocate for Mrs. D. to receive adequate pain relief. Mrs. D. visits her physician and receives a different opioid medication that is given around-the-clock, plus an additional medication to help with any breakthrough pain. 2. What type of drug is given for breakthrough pain? 3. After 1 week, Mr. D. finds Mrs. D. awake but lethargic, and speaking with slurred words. What do you think has happened? What should Mr. D. do? 4. Mrs. D. is taken to the emergency department and is treated for oversedation. Her physician is contacted, and the medication doses are adjusted to a lower dose. How can this problem be prevented in the future? Regardless of the drug(s) used for the pain management regimen, always remember that individualization of treatment is one of the most important considerations for effective and quality pain control. Also consider implementing the following: • At the initiation of pain therapy, conduct a review of all relevant histories, laboratory test values, nurse-related charting entries, and diagnostic study results in the patient's medical record. If there are underlying problems, consider these variables while never forgetting to treat the patient with dignity and empathy. Never let compounding variables and any other problems overshadow the fact that there is a patient who is in pain and deserving of safe, quality care. Always look and listen! • Develop goals for pain management in 603 conjunction with the patient, family members, significant others, and/or caregiver. These goals include improving the level of comfort with increased levels of activities of daily living and ambulation. • Collaborate with other members of the health care team to select a regimen that will be easy for the patient to follow while in the hospital and, if necessary, at home (e.g., for cancer patients and other patients with chronic pain). • Be aware that most regimens for acute pain management include treatment with short-acting opioids plus the addition of other medications such as NSAIDs. • Be familiar with equianalgesic doses of opioids, because lack of knowledge may lead to inadequate analgesia or overdose. • Use an analgesic appropriate for the situation (e.g., short-acting opioids for severe pain secondary to a myocardial infarction, surgery, or kidney stones). For cancer pain, the regimen usually begins with short-acting opioids with eventual conversion to sustained-release formulations. • Use preventative measures to manage adverse effects. In addition, a switch is made to another opioid as soon as possible if the patient finds that the medication is not controlling the pain adequately. • Consider the option of analgesic adjuvants, 604 especially in cases of chronic pain or cancer pain; these might include other prescribed drugs such as NSAIDs, acetaminophen, corticosteroids, anticonvulsants, tricyclic antidepressants, neuroleptics, local anesthetics, hydroxyzine, and/or psychostimulants. Over-the-counter drugs and herbals may be helpful. • Be alert to patients with special needs, such as patients with breakthrough pain. Generally, the drug used to manage such pain is a short-acting form of the longer-acting opioid being given (e.g., immediate-release morphine for breakthrough pain while sustained-release morphine is also used). • Identify community resources that can assist the patient, family members, and/or significant others. These resources may include various websites for patient education such as www.theacpa.org, www.painconnection.org, and www.painaction.com. Many other pain management sites may be found on the Internet by using the search terms pain, pain clinic, or pain education and looking for patientfocused materials/sites. • Conduct frequent online searches to remain current on the topic of pain management, pain education, drug and non-drug therapeutic regimens for pain, and special pain situations. The following professional nurse and/or prescriberfocused websites are listed at www.painedu.org/resources.asp as resources for the 605 topic of general pain management: www.aapainmanage.org, www.painmed.org, www.painfoundation.org, www.ampainsoc.org, www.aspmn.org, www.asam.org, www.paineducators.org, www.asra.com, www.iasppain.org, www.painpolicy.wisc.edu, www.painmedicinenews.com, www.pain-topics.org, www.pain.com, and www.painandhealth.org. On the topic of chronic pain, websites are as follows: www.theacpa.org and www.arthritis.org. On the topic of cancer pain, websites are as follows: www.cancer.org, www.apos-society.org, www.asco.org, www.cancercare.org, www.cancer.gov, and www.ons.org. • Because fall prevention is of utmost importance in patient care (after the ABCs [airway, breathing, circulation] of care are addressed), monitor the patient frequently after an analgesic is given. Frequent measurement of vital signs, inclusion of the patient in a frequent watch program, and/or use of bed alarms is encouraged. • Restraints may cause many injuries; therefore if restraints are necessary, follow the appropriate policies and procedures. Assess, monitor, evaluate, and document the reason for the restraint; also document the patient's behavior, the type of restraint used, and the assessment of the patient after the placement of restraints. Use of restraints has been largely replaced with a bed watch system and the use of bed and/or 606 wheelchair alarms. Give instructions to the patient, family members, and/or caregivers about the risk for falls and the need for safety measures. Restraints are not used in long-term health care settings. Evaluation Positive therapeutic outcomes of acetaminophen use are decreased symptoms, fever, and pain. Monitor for the adverse reactions of anemias and liver problems due to hepatotoxicity, and report patient complaints of abdominal pain and/or vomiting to the prescriber. During and after the administration of nonopioid analgesics, such as tramadol, as well as opioids and mixed opioid agonists, monitor the patient for both therapeutic effects and adverse effects frequently and as needed. Therapeutic effects of analgesics include increased comfort levels as well as decreased complaints of pain and longer periods of comfort, with improvements in performance of activities of daily living, appetite, and sense of well-being. Monitoring for adverse effects will vary with each drug (see earlier discussions), but effects may consist of nausea, vomiting, constipation, dizziness, headache, blurred vision, decreased urinary output, drowsiness, lethargy, sedation, palpitations, bradycardia, bradypnea, dyspnea, and hypotension. If the patient's vital signs change, the patient's condition declines, or pain continues, contact the prescriber immediately and continue to closely monitor the patient. Respiratory depression may be manifested by a respiratory rate of less than 10 breaths/min, dyspnea, diminished breath sounds, and/or shallow breathing. Include a review of the effectiveness of multimodal and nonpharmacologic approaches to pain management in your evaluation. Patient-Centered Care: Patient Teaching 607 • Capsaicin is a topical product made from different types of peppers that may help with muscle pain and joint/nerve pain. It may cause local topical reactions, so be sure to share information with the patient about its safe use. • Opioids are not to be used with alcohol or with other central nervous system depressants, unless ordered, because of worsening of the depressant effects. Emphasize the importance of patients and caregivers knowing the ingredients of over-thecounter as well as prescribed medications. This is especially important if a patient is taking acetaminophen and also a combination opioid prescribed medication such as hydrocodone (Vicodin, Norco) or oxycodone (Percocet, Tylox) because of danger of overdosage with the acetaminophen (see previous discussions in this chapter). • A holistic approach to pain management may be appropriate, with the use of complementary modalities including the following: biofeedback, imagery, relaxation, deep breathing, humor, pet therapy, music therapy, massage, use of hot or cold compresses, and use of herbal products. • Dizziness, difficulty breathing, low blood pressure, excessive sleepiness (sedation), confusion, or loss of memory must be promptly reported to the nurse, prescriber, or other health care providers. • Opioids may result in constipation, so forcing fluids (up to 3 L/day unless contraindicated), increasing fiber consumption, and exercising as tolerated is recommended. Stool softeners may also be necessary. • Report any nausea or vomiting. Antiemetic drugs may be prescribed. • Any activities requiring mental clarity or alertness may need to be avoided if experiencing drowsiness or sedation. Ambulate with caution and/or assistance as needed. • It is important for the patient to share any history of addiction with health care providers, but when such a patient experiences pain and is in need of opioid analgesia, understand that the patient has a right to comfort. Any further issues with addiction may be managed during and after the 608 use of opioids. Keeping an open mind regarding the use of resources, counseling, and other treatment options is important in dealing with addictive behaviors. • If pain is problematic and not managed by monotherapy, a combination of a variety of medications may be needed. Other drugs that may be used include antianxiety drugs, sedatives, hypnotics, or anticonvulsants. • For the cancer patient or patient with special needs, the prescriber will monitor pain control and the need for other options for therapy or for dosing of drugs. For example, the use of transdermal patches, buccal tablets, and continuous infusions while the patient remains mobile or at home is often helpful in pain management. It is also important to understand that if morphine or morphine-like drugs are being used, the potential for addiction exists; however, in specific situations, the concern for quality of life and pain management is more important than the concern for addiction. • Most hospitals have inpatient and outpatient resources such as pain clinics. Patients need to constantly be informed and aware of all treatment options and remain active participants in their care for as long as possible. • Tolerance does occur with opioid use, so if the level of pain increases while the patient remains on the prescribed dosage, the prescriber or health care provider must be contacted. Dosages must not be changed, increased, or doubled unless prescribed. Key Points • Pain is individual and involves sensations and emotions that are unpleasant. It is influenced by age, culture, race, spirituality, and all other aspects of the individual. • Pain is associated with actual or potential tissue damage and may be exacerbated or alleviated 609 depending on the treatment and type of pain. • Types of analgesics include the following: • Nonopioids, including acetaminophen, aspirin, and NSAIDs. • Opioids, which are natural or synthetic drugs that either contain or are derived from morphine (opiates) or have opiatelike effects or activities (opioids), and opioid agonist-antagonist drugs. • Pediatric dosages of morphine must be calculated very cautiously with close attention to the dose and kilograms of body weight. Cautious titration of dosage upward is usually the standard. • Older adult patients may react differently than expected to analgesics, especially opioids and opioid agonists-antagonists. • In treating older adults, remember that these patients experience pain the same as the general population does, but they may be reluctant to report pain and may metabolize opiates at a slower rate and thus are at increased risk for adverse effects such as sedation and respiratory depression. The best rule is to start with low dosages, reevaluate often, and go slowly during upward titration. Critical Thinking Exercises 1. The nurse is about to administer 5 mg of morphine sulfate intravenously to a patient with severe postoperative pain, as ordered. What priority 610 assessment data must be gathered before and after administering this drug? Explain your answer. 2. A young woman is brought by ambulance to the emergency department because she was found unconscious next to an empty bottle of acetaminophen. While the medical team assesses her, the nurse goes to question the family about the situation. What is the most important piece of information to know about this possible overdose? Explain your answer. Review Questions 1. For best results when treating severe pain associated with pathologic spinal fractures related to metastatic bone cancer, the nurse should remember that the best type of dosage schedule is to administer the pain medication is which of these? a. As needed b. Around the clock c. On schedule during waking hours only d. Around the clock, with additional doses as needed for breakthrough pain 2. A patient is receiving an opioid via a PCA pump as part of his postoperative pain management program. During rounds, the nurse finds him unresponsive, with respirations of 8 breaths/min and blood pressure of 102/58 mm Hg. After stopping the opioid infusion, what should the nurse do next? a. Notify the charge nurse. b. Draw arterial blood gases. c. Administer an opiate antagonist per standing orders. 611 d. Perform a thorough assessment, including mental status examination. 3. A patient with bone pain caused by metastatic cancer will be receiving transdermal fentanyl patches. The patient asks the nurse what benefits these patches have. The nurse's best response includes which of these features? a. More constant drug levels for analgesia b. Less constipation and minimal dry mouth c. Less drowsiness than with oral opioids d. Lower dependency potential and no major adverse effects 4. Intravenous morphine is prescribed for a patient who has had surgery. The nurse informs the patient that which common adverse effects can occur with this medication? (Select all that apply.) a. Diarrhea b. Constipation c. Pruritus d. Urinary frequency e. Nausea 5. Several patients have standard orders for acetaminophen as needed for pain. While reviewing their histories and assessments, the nurse discovers that one of the patients has a contraindication to acetaminophen therapy. Which patient should receive an alternate medication? a. A patient with a fever of 103.4°F (39.7°C) b. A patient admitted with deep vein thrombosis c. A patient admitted with severe hepatitis d. A patient who had abdominal surgery 1 week earlier 612 6. The nurse is administering an intravenous dose of morphine sulfate to a 48-year-old postoperative patient. The dose ordered is 3 mg every 3 hours as needed for pain. The medication is supplied in vials of 4 mg/mL. How much will be drawn into the syringe for this dose? 7. An opioid analgesic is prescribed for a patient. The nurse checks the patient's medical history knowing this medication is contraindicated in which disorder? (Select all that apply.) a. Renal insufficiency b. Severe asthma c. Sleep apnea d. Severe head injury e. Liver disease 8. A patient with renal cancer needs an opiate for pain control. Which opioid medication would be the safest choice for this patient? a. fentanyl b. hydromorphone (Dilaudid) c. morphine sulfate d. methadone (Dolophine) References Acetadote (acetylcysteine) injection (prescribing information). [Cumberland Pharmaceuticals, Nashville, TN; Available at] www.acetadote.net; 2013. The American Pain Society in conjunction with the American Academy of Pain Medicine. Guideline for the use of chronic opioid therapy in chronic noncancer 613 pain: Evidence review. [Available at] http://americanpainsociety.org/uploads/education/guideline opioid-therapy-cncp.pdf. Assil K. Opioids: prescribe with care. PainEDU: Improving Pain Treatment Through Education. [September 28, 2016; Available at] www.painedu.org. Dowell D, Haegerich TM, Chou R. CDC guideline for prescribing opioids for chronic pain—United States, 2016. Morbidity and Mortality Weekly Report. Recommendations and Reports. 2016;65:1. Duke G, Haas BK, Yarborough S, et al. Pain management knowledge and attitudes of baccalaureate nursing students and faculty. Pain Management Nursing. 2013;14:11–19. Duragesic (fentanyl) transdermal system (prescribing information). [Ortho-McNeil-Janssen Pharmaceuticals, Titusville, NJ; Available at] www.duragesic.com; 2015. Franklin GM, American Academy of Neurology. Opioids for chronic noncancer pain: a position paper of the American Academy of Neurology. Neurology. 2014;83:1277. Gilron I, Baron R, Jensen T. Neuropathic pain: principles of diagnosis and treatment. Mayo Clinic Proceedings. 2015;90:532. Jarvis C. Physical examination and health assessment. 7th ed. Saunders: St Louis; 2016. Lidoderm (lidocaine patch 5%) (prescribing information). [Endo Pharmaceuticals, Chadds Ford, PA; Available at] www.lidoderm.com/prescrib.aspx; 2015. Melzack R, Wall P. Pain mechanisms: a new theory. Science. 1965;150(3699):971–979. 614 US Food and Drug Administration. Opioid pain or cough medicines combined with benzodiazepines: drug safety communication—FDA requiring boxed warning about serious risks and death. [Available at] www.fda.gov/NewsEvents/Newsroom/PressAnnouncement US Food and Drug Administration. FDA limits acetaminophen in prescription combination products; requires liver toxicity warnings. [Available at] www.fda.gov/NewsEvents/Newsroom/PressAnnouncement 615 11 General and Local Anesthetics OBJECTIVES When you reach the end of this chapter, you will be able to do the following: 1. Define anesthesia. 2. Describe the basic differences between general and local anesthesia. 3. List the most commonly used general and local anesthetics and associated risks. 4. Discuss the differences between depolarizing neuromuscular blocking drugs and nondepolarizing blocking drugs and their impact on the patient. 5. Compare the mechanisms of action, indications, adverse effects, routes of administration, cautions, contraindications, and drug interactions for general and local anesthesia as well as drugs used for moderate or conscious sedation. 6. Develop a nursing care plan for patients before anesthesia (preanesthesia), during anesthesia, and after anesthesia (postanesthesia) related to general anesthesia. 7. Develop a nursing care plan for patients undergoing local anesthesia and/or moderate or conscious sedation. 616 KEY TERMS Adjunct anesthetics Drugs used in combination with anesthetic drugs to control the adverse effects of anesthetics or to help maintain the anesthetic state in the patient. (See balanced anesthesia.) Anesthesia The loss of the ability to feel pain resulting from the administration of an anesthetic drug. Anesthetics Drugs that depress the central nervous system (CNS) or peripheral nerves to produce decreased or loss of consciousness or muscle relaxation. Anesthesia provider A health care professional who is licensed to provide anesthesia. Can be an anesthesiologist (MD), a certified registered nurse anesthetist (CRNA), or an anesthesia assistant. Balanced anesthesia The practice of using combinations of different drug classes rather than a single drug to produce anesthesia. General anesthesia A drug-induced state in which the CNS nerve impulses are altered to reduce pain and other sensations throughout the entire body. It involves complete loss of consciousness and depression of respiratory drive. Local anesthesia A drug-induced state in which peripheral or spinal nerve impulses are altered to reduce or eliminate pain and other sensations in tissues innervated by these nerves. Malignant hyperthermia A genetically linked major adverse reaction to general anesthesia characterized by a rapid rise in body temperature as well as tachycardia, tachypnea, and sweating. Moderate sedation A milder form of general anesthesia that causes partial or complete loss of consciousness but does not generally reduce normal respiratory drive (also referred to as conscious sedation). Monitored anesthesia care Monitored anesthesia care (MAC) is a 617 planned procedure in which the patient undergoes local anesthesia along with sedation and analgesia. Overton-Meyer theory A theory describing the relationship between the lipid solubility of anesthetic drugs and their potency. Spinal anesthesia Local anesthesia induced by injection of an anesthetic drug near the spinal cord to anesthetize nerves that are distal to the site of injection. Overview Anesthetics are drugs that reduce or eliminate pain by depressing nerve function in the central nervous system (CNS) and/or the peripheral nervous system (PNS). This state of reduced neurologic function is called anesthesia. Anesthesia is further classified as general or local. General anesthesia involves complete loss of consciousness and loss of body reflexes, including respiratory muscles. This loss of normal respiratory function requires mechanical or manual ventilatory support to avoid brain damage and suffocation (death from respiratory arrest). Local anesthesia does not involve paralysis of respiratory function but only elimination of pain sensation in the tissues innervated by anesthetized nerves. Functions of the parasympathetic nervous system, a branch of the autonomic nervous system, may also be affected. Monitored anesthesia care (MAC) is a planned procedure in which the patient undergoes local anesthesia along with sedation and analgesia. The fundamental elements of MAC include safe sedation, control of anxiety, and pain control. Patients undergoing MAC are able to answer questions appropriately and protect their airways. MAC allows the patient to be discharged soon after the procedure. General Anesthetics General anesthetics are drugs used to produce profound neurosensory depression to allow for surgical procedures. General anesthetics are given only under controlled conditions by 618 anesthesia providers (either an anesthesiologist, a nurse anesthetist [CRNA], or anesthesia assistant). General anesthesia is achieved by the use of one or more drugs. Often a synergistic combination of drugs is used, which allows for smaller doses of each drug and better control of the patient's anesthetized state. Inhalational anesthetics are volatile liquids or gases that are vaporized or mixed with oxygen or medical air to induce anesthesia. Box 11.1 offers a historical perspective on general anesthesia. Box 11.1 General Anesthesia: A Historical Perspective Until recently, general anesthesia was described as having several definitive stages. This was especially true with the use of many of the ether-based inhaled anesthetic drugs. Features of these distinctive stages were easily observable to the trained eye. They included specific physical and physiologic changes that progressed gradually and predictably with the depth of the patient's anesthetized state. Gradual changes in pupil size, progression from thoracic to diaphragmatic breathing, changes in vital signs, and several other changes all characterized the various stages. Newer inhalational and intravenous general anesthetic drugs, however, often have a much more rapid onset of action and body distribution. As a result, the specific stages of anesthesia once observed with older drugs are no longer sufficiently well defined to be observable. Thus the concept of stages of anesthesia is an outdated one in most modern surgical institutions. Registered nurses who pursue advanced training to become anesthesia providers often find this to be a rewarding and interesting area of nursing practice. Some nurses also find that this type of work offers greater flexibility in their work schedules than do other practice areas. Parenteral anesthetics (Table 11.1) are given intravenously and are used for induction and/or maintenance of general anesthesia, induction of amnesia, and as adjuncts to inhalation-type anesthetics (Table 11.2). The specific goal varies with the drug. Common 619 intravenous anesthetic drugs include drugs classified solely as general anesthetics, such as etomidate and propofol. TABLE 11.1 Parenteral General Anesthetics Generic Name etomidate ketamine methohexital propofol thiopental Trade Name Amidate Ketalar Brevital Diprivan Pentothal TABLE 11.2 Inhalational General Anesthetics Generic Name Inhaled Gas nitrous oxide (laughing gas) Inhaled Volatile Liquid Desflurane Isoflurane Sevoflurane Trade Name Suprane Forane Ultane Adjunct anesthetics, or simply adjuncts, are also used. Adjunct is a general term for any drug that enhances clinical therapy when used simultaneously with another drug. Adjunct drugs can be thought of as “helper drugs.” They are used simultaneously with general anesthetics for anesthesia initiation (induction), sedation, reduction of anxiety, and amnesia. Adjuncts include neuromuscular blocking drugs (NMBDs); see the section titled “Neuromuscular Blocking Drugs” later in this chapter), sedative-hypnotics or anxiolytics (see Chapter 12) such as propofol (this chapter), benzodiazepines (e.g., diazepam, midazolam), barbiturates (e.g., thiopental; see Chapter 12), opioid analgesics (e.g., fentanyl; see Chapter 10), anticholinergics (e.g., atropine; see Chapter 21), and antiemetics (e.g., ondansetron; see Chapter 52). Note that propofol can be used as a general anesthetic and/or sedative-hypnotic, depending on the dose. The simultaneous use of both general anesthetics and adjuncts is called balanced anesthesia. Common 620 adjunctive anesthetic drugs are listed in Table 11.3. TABLE 11.3 Adjunctive Anesthetic Drugs Pharmacologic Indications/Uses Class alfentanil (Alfenta), fentanyl Opioid Anesthesia induction (Sublimaze), sufentanil (Sufenta) analgesic diazepam (Valium), midazolam Benzodiazepine Amnesia and anxiety (Versed) reduction atropine, glycopyrrolate Anticholinergic Drying up of excessive (Robinul) secretions meperidine (Demerol), morphine Opioid Pain prevention and pain analgesic relief hydroxyzine (Atarax, Vistaril), Antihistamine Sedation, prevention of nausea promethazine (Phenergan) and vomiting, anxiety reduction pentobarbital (Nembutal), SedativeAmnesia and sedation secobarbital (Seconal) hypnotic dexmedetomidine (Precedex) Alpha2 agonist Sedation Drug Mechanism of Action and Drug Effects Many theories have been proposed to explain the actual mechanism of action of general anesthetics. The drugs vary widely in their chemical structures, and their mechanisms of action are not easily explained by a structure-receptor relationship. The concentrations of various anesthetics required to produce a given state of anesthesia also differ greatly. The Overton-Meyer theory has been used to explain some of the properties of anesthetic drugs. It proposes that, for all anesthetics, potency varies directly with lipid solubility. In other words, fat-soluble drugs are stronger anesthetics than water-soluble drugs. Nerve cell membranes have high lipid content, as does the brain, the spinal cord, and the blood-brain barrier. Lipid-soluble anesthetic drugs can therefore easily cross the blood-brain barrier to concentrate in nerve cell membranes. The overall effect of general anesthetics is a progressive reduction of sensory and motor CNS functions. The degree and speed of this process vary with the anesthetics and adjuncts used along with 621 their dosages and routes of administration. General anesthesia initially produces a loss of the senses of sight, touch, taste, smell, and hearing along with loss of consciousness. Cardiac and pulmonary functions are usually the last to be interrupted because they are controlled by the medulla of the brainstem. These are the classical “stages” of anesthesia. Mechanical ventilatory support is absolutely necessary. In more extensive surgical procedures, especially those involving the heart, pharmacologic cardiac support involving adrenergic drugs (see Chapter 18) and inotropic drugs (see Chapter 24) may also be required. The reactions of various body systems to general anesthetics are further described in Table 11.4. TABLE 11.4 Effects of Inhaled and Intravenous General Anesthetics Organ/System Respiratory system Cardiovascular system Cerebrovascular system Gastrointestinal system Renal system Skeletal muscles Cutaneous circulation Central nervous system (CNS) Reaction Impaired oxygenation, depressed airway-protective mechanisms, airway irritation and possible laryngospasm Depressed myocardium, hypotension and tachycardia, bradycardia in response to vagal stimulation Increased intracranial pressure Reduced hepatic blood flow and thus reduced hepatic clearance Decreased glomerular filtration Skeletal muscle relaxation Vasodilation CNS depression; blurred vision; nystagmus; progression of CNS depression to decreased alertness, sensorium, and decreased level of consciousness Indications General anesthetics are used to produce unconsciousness as well as some degree of relaxation of skeletal and visceral smooth muscles for surgical procedures as well as in electroconvulsive therapy for severe depression (see Chapter 16). 622 Contraindications Contraindications to the use of anesthetic drugs include known drug allergy. Depending on the drug type, contraindications may also include pregnancy, narrow-angle glaucoma, acute porphyria, and known susceptibility to malignant hyperthermia (see the section titled “Adverse Effects”). Patient-Centered Care: Lifespan Considerations for the Older Adult Patient Anesthesia • The older adult patient is affected more adversely by anesthesia than the young or middle-aged adult. With aging comes the deterioration of organ systems. A decline in liver function results in the decreased metabolism of drugs. A decline in renal function leads to decreased drug excretion. Either of these can lead to drug toxicity, unsafe levels, and/or overdose. If both of these organs are not functioning properly, the risk for drug toxicity or overdose is even greater. In addition, older adult patients are more sensitive to the effects of drugs affecting the central nervous system. • The presence of cardiac and respiratory diseases places the older adult patient at higher risk for cardiac dysrhythmias, hypotension, respiratory depression, atelectasis, and/or pneumonia during the postanesthesia and postoperative phases. • The practice of polypharmacy is yet another concern in the older adult patient with regard to the administration of any type of anesthetic. Because of the presence of various agerelated diseases, the older adult patient is more likely to be taking more than one medication. The more drugs a patient is taking, the higher the risk for adverse reactions and drug-drug interactions, including interactions with anesthetics. 623 Adverse Effects Adverse effects of general anesthetics are dose dependent and vary with the individual drug. The heart, peripheral circulation, liver, kidneys, and respiratory tract are the sites primarily affected. One major complication of general anesthesia is hypotension, affecting perfusion of the organs mentioned earlier. With the development of newer drugs, many of the unwanted adverse effects characteristic of the older drugs (such as hepatotoxicity and myocardial depression) are now less frequent. In addition, many of the bothersome adverse effects—such as nausea, vomiting, and confusion—are less common with the widespread use of balanced anesthesia. Even with the use of the newer anesthetic agents, the incidence of postoperative nausea and vomiting (PONV) remains one of the most common reasons children and adults have extended/protracted stays in the postanesthesia care unit (PACU)/recovery room. There is no exact cause of PONV; it is thought to be due to multiple factors. Pain is associated with PONV; therefore the adequate treatment of pain frequently decreases nausea. Substance abuse can predispose a patient to anesthetic-induced complications. Malignant hyperthermia is an uncommon, but potentially fatal, genetically linked adverse metabolic reaction to general anesthesia. It is classically associated with the use of volatile inhalational anesthetics as well as the depolarizing NMBD succinylcholine. Signs include a rapid rise in body temperature, tachycardia, tachypnea, and muscular rigidity. Patients known to be at greater risk for malignant hyperthermia include children, adolescents, and individuals with muscular and/or skeletal abnormalities. Malignant hyperthermia is treated with cardiorespiratory supportive care as needed to stabilize heart and lung function, along with the skeletal muscle relaxant dantrolene (see Chapter 12). In fact, by law, all health care institutions that provide general anesthesia must keep a certain amount of dantrolene on hand in the event that a case of malignant hyperthermia should occur. Toxicity and Management of Overdose In large doses, anesthetics are potentially life threatening, with 624 cardiac and respiratory arrest as the ultimate causes of death. However, these drugs are almost exclusively administered in a very controlled environment by personnel trained in advanced cardiac life support. General anesthetics are very quickly metabolized. The newer drugs are much more lipophilic than the older drugs, contributing to the “fast on” and “fast off” action of these drugs. These factors combined make an anesthetic overdose rare and easily reversible. Owing to advances in pharmacology, anesthesia is safer today than it is has ever been before. Interactions The drugs that interact with general anesthetics include antihypertensives and beta blockers, which have additive effects when combined with general anesthetics (i.e., increased hypotensive effects from antihypertensives and increased myocardial depression from beta blockers). No significant interactions from laboratory tests have been reported. Drug Profiles The dose of any anesthetic depends on the complexity of the surgical procedure to be performed and the physical characteristics of the patient. All of the general anesthetics have a rapid onset of action and are eliminated rapidly upon discontinuation. Anesthesia is maintained intraoperatively by continuous administration of the drug. dexmedetomidine Dexmedetomidine (Precedex) is an alpha2 adrenergic receptor agonist (see Chapter 18). It produces dose-dependent sedation, decreased anxiety, and provides analgesia without respiratory depression. It is used for procedural sedation and for surgeries of short duration. It has a short half-life, and the patient awakens quickly upon withdrawal of the drug. Dexmedetomidine is also commonly used in the intensive care setting for sedation of mechanically ventilated patients; it is also used in patients experiencing alcohol withdrawal. Lower doses may be needed with 625 the concurrent administration of anesthetics, sedatives, or opioids. Side effects include hypotension, bradycardia, transient hypertension, and nausea. Although the prescribing information states that dexmedetomidine is to be used for no more than 24 hours, multiple studies have shown it to be safe and effective at longer durations, and it is commonly used in clinical practice for more than 24 hours. ketamine Ketamine is a unique drug with multiple properties. Most commonly given intravenously, it can also be given intramuscularly or subcutaneously; it is used for both general anesthesia and moderate sedation. Ketamine is commonly used in the emergency department for setting broken bones. It binds to receptors in both the CNS and PNS, including opioid receptors and, most importantly, the N-methyl-D-aspartate (NMDA) receptors located in the dorsal horn of the spinal cord. The drug is highly lipid soluble and penetrates the blood-brain barrier rapidly, resulting in a rapid onset of action. It has a low incidence of reduction of cardiovascular, respiratory, and bowel function. Ketamine actually has bronchodilating properties, making it an excellent choice for the induction of anesthesia in the asthmatic patient. Adverse effects can include disturbing psychomimetic effects, including hallucinations. However, these are less likely to occur when benzodiazepines (see Chapter 12) are coadministered with the drug. Ketamine is contraindicated in cases of known drug allergy. nitrous oxide Nitrous oxide, also known as laughing gas, is the only inhaled gas currently used as a general anesthetic. It is the weakest of the general anesthetic drugs but has very good analgesic properties and is used primarily for dental procedures or as a supplement to other, more potent anesthetics. Owing to its low potency, nitrous oxide is rarely administered as the sole anesthetic for major surgeries and is often administered in addition to one of the other commonly used inhaled agents (sevoflurane and desflurane). High concentrations of nitrous oxide have also been linked to an increased incidence of PONV in operations that require more than 1 hour. 626 propofol Propofol (Diprivan) is a parenteral general anesthetic used for the induction and maintenance of general anesthesia and also for sedation during mechanical ventilation in intensive care unit (ICU) settings. In lower doses, it can also be used as a sedative-hypnotic for moderate sedation. Some states, specifically under a state's nurse practice act, allow nurses to administer propofol as part of a moderate sedation protocol; however, many states prohibit administration by nurses. Propofol is typically well tolerated, producing few undesirable effects. Propofol is a lipid-based emulsion, and if given for prolonged periods or in conjunction with total parenteral nutrition, serum lipids must be monitored. sevoflurane Sevoflurane (Ultane) and desflurane (Suprane) are widely used inhaled volatile anesthetics. Both drugs have rapid onset and elimination, making them especially useful in all surgical settings. Unlike inhaled anesthetics of the past, which left patients drowsy after waking from anesthesia, these two commonly used anesthetics are eliminated very quickly from the body. Because of this rapid elimination, there is less incidence of PONV and complications involving respiratory difficulty (such as airway obstruction). Unlike sevoflurane, desflurane has been known to cause airway irritation and coughing. Drugs for Moderate Sedation Moderate sedation, conscious sedation, and procedural sedation are synonymous terms for anesthesia that does not cause complete loss of consciousness and does not normally cause respiratory arrest. As more minor surgical procedures move from traditional operating room settings to outpatient surgery centers or office-based practices, the use of moderate sedation will continue to increase. Moderate sedation allows the patient to relax and have markedly reduced or no anxiety yet still maintain his or her own airway and respond to verbal commands. Standards must be followed when moderate sedation is provided. Health care personnel who 627 administer moderate sedation are required to have advanced cardiac life support training; one professional must have no duties other than to monitor the patient, and someone with the ability to intubate the patient must be present in case the patient slips into a deeper state of sedation and is unable to maintain an open airway. The American Society of Anesthesia has published guidelines on moderate sedation, which can be found at www.asahq.org. The most commonly used drugs for moderate sedation include a short-acting benzodiazepine, usually midazolam (see Chapter 12), with a short-acting opioid, usually fentanyl or morphine. Propofol is also commonly used. Propofol, when used for moderate sedation, is usually given by an anesthesia provider, although there is some debate among physician specialties as to who should be allowed to administer it. If midazolam is combined with an opioid such as fentanyl or morphine, the dose should be reduced by 30% to 50%. Mild amnesia is also a common effect due to the midazolam. This is often desirable for helping patients to avoid recall of painful medical procedures. However, amnesia is not guaranteed. Benzodiazepines (i.e., midazolam) work very similarly to alcohol in the body. If the patient regularly consumes alcohol, this sensitization may require a higher dose to achieve amnesia. Nevertheless, the physician, nurse, or other health care provider in the surgical area should never assume that the patient will not remember things that are said during sedation/anesthesia. The nurse should always behave and speak as though the patient were completely awake even if the patient is mildly sedated or under a general anesthetic. Moderate sedation is associated with a more rapid recovery time than general anesthesia as well as a better safety profile because of lower cardiopulmonary risks. The oral route of drug administration is commonly used in pediatric patients. This often involves administering an oral syrup form of midazolam with or without concurrent use of injected medications such as opiates. It is especially helpful for pediatric patients who must undergo uncomfortable procedures such as wound suturing or diagnostic procedures requiring reduced movement, such as computed tomography and magnetic resonance imaging. See the box titled “Patient-Centered Care: Lifespan Considerations for the Pediatric Patient” for other considerations. 628 Local Anesthetics Local anesthetics are the second major class of anesthetics. They reduce pain sensations at the level of peripheral nerves, although this can also involve neuraxial or central anesthesia (see later). They are also called regional anesthetics because they render a specific portion of the body insensitive to pain. They work by interfering with nerve transmission in specific areas of the body, blocking nerve conduction only in the area to which they are applied, without causing loss of consciousness. They are most commonly used in clinical settings in which loss of consciousness is undesirable or unnecessary. These include childbirth and other situations in which spinal anesthesia is desired, dental procedures, suturing of skin lacerations, and diagnostic procedures. Most local anesthetics belong to one of two major groups of organic compounds: esters and amides. They are classified as either parenteral (injectable) or topical anesthetics. Parenteral anesthetics are most commonly given intravenously but may also be administered by various spinal injection techniques (Box 11.2). Topical anesthetics are applied directly to the skin and mucous membranes. They are available in the form of solutions, ointments, gels, creams, powders, suppositories, and ophthalmic drops. See Table 11.5. Box 11.2 Types of Local Anesthesia Central • Spinal or neuraxial or central anesthesia: Anesthetic drugs are injected into the area near the spinal cord within the vertebral column. Neuraxial or central anesthesia is commonly accomplished by one of two injection techniques: intrathecal and epidural. • Intrathecal anesthesia involves injection of anesthetic into the subarachnoid space. Intrathecal anesthesia is commonly used for patients undergoing major 629 abdominal or limb surgery for whom the risks of general anesthesia are too high or for patients who prefer this technique instead of complete loss of consciousness during their surgical procedure. More recently, intrathecal injection of anesthetics through implantable drug pumps is being used even on an outpatient basis in patients with severe chronic pain syndromes, such as those resulting from occupational injuries. • Epidural anesthesia involves injection of anesthetic via a small catheter into the epidural space without puncturing the dura. Epidural anesthesia is commonly used to reduce maternal discomfort during labor and delivery and to manage postoperative acute pain after major abdominal or pelvic surgery. This route is becoming more popular for the administration of opioids for pain management. Peripheral • Infiltration: Small amounts of anesthetic solution are injected into the tissue that surrounds the operative site. This approach to anesthesia is commonly used for such procedures as wound suturing and dental surgery. Often drugs that cause constriction of local blood vessels (e.g., epinephrine, cocaine) are also administered to limit the site of action to the local area. • Nerve block: Anesthetic solution is injected at the site where a nerve innervates a specific area, such as a tissue. This allows large amounts of anesthetic drug to be delivered to a very specific area without affecting the whole body. Nerve block is often reserved for more difficult-to-treat pain syndromes such as cancer pain and chronic orthopedic pain. • Topical anesthesia: The anesthetic drug is applied directly to the surface of the skin, eye, or any mucous membrane to relieve pain or prevent it from being sensed. It is commonly used for diagnostic eye examinations and skin suturing. 630 TABLE 11.5 Selected Topical Anesthetics Drug benzocaine (Dermoplast, Lanacane, Solarcaine) cocaine dibucaine (Nupercainal) dibucaine dyclonine (Dyclone, Sucrets) ethyl chloride (Chloroethane) lidocaine (Lidoderm) proparacaine (Alcaine, Ophthetic) prilocaine/lidocaine (EMLA) tetracaine (Pontocaine) Route Topical, aerosol, and spray Topical Injection and topical Topical Topical Topical Topical Ophthalmic Topical Injection, topical, and ophthalmic The injection of parenteral anesthetic drugs into the area near the spinal cord is known as spinal or neuraxial anesthesia. This type of anesthesia is generally used to block all peripheral nerves that branch out distal to the injection site. The result is elimination of pain and paralysis of the skeletal and smooth muscles of the corresponding innervated tissues. Some of the medications used for spinal anesthesia include the opioids morphine, hydromorphone, fentanyl, and meperidine (see Chapter 10) and the local anesthetics lidocaine and bupivacaine. Because spinal anesthesia does not depress the CNS at a level that causes loss of consciousness, it can be thought of as a large-scale type of local rather than general anesthesia. Common types of local anesthesia are described in Box 11.2. The parenteral local anesthetic drugs and their pharmacokinetics are summarized in Table 11.6. TABLE 11.6 Selected Parenteral Local Anesthetic Drugs* Generic Name lidocaine mepivacaine procaine tetracaine Trade Name Xylocaine Carbocaine Novocain Pontocaine Potency Moderate Moderate Lowest Highest * Onset Immediate Immediate 2–5 min 5–10 min Duration 60–90 min 120–150 min 30–60 min 90–120 min Other common parenteral anesthetic drugs include bupivacaine (Marcaine, Sensorcaine), chloroprocaine (Nesacaine), etidocaine (Duranest), 631 propoxycaine (Ravocaine), and ropivacaine (Naropin). Patient-Centered Care: Lifespan Considerations for the Pediatric Patient Moderate or Conscious Sedation • The American Academy of Pediatrics recommends that moderate or conscious sedation be used to reduce anxiety, pain, and fear in the pediatric patient. The use of moderate sedation in the pediatric patient allows a procedure to be performed restraint free in most situations while keeping the patient responsive. • Medications often used for procedural sedation include the following: • Opioid analgesics—morphine sulfate, fentanyl • Benzodiazepines—midazolam, diazepam • Barbiturates—pentobarbital, mehohexital, thiopental • Miscellaneous agents—nitrous oxide, ketamine, propofol, dexmedetomidine • Medication dosing is calculated based on weight, but the response varies significantly from child to child. The most appropriate actions include the following: • Always consider beginning with the lowest recommended dose, or even half that, and titrate as needed. • Keep reversal agents available at the bedside and always double-check proper doses. Reversal agents include naloxone for opioids and flumazenil for benzodiazepines. • Discharge status of the pediatric patient depends on the type of drug and drug combinations used. Discharge after conscious or moderate sedation is based mainly on whether the following criteria are met: • Patient is alert and oriented compared with the baseline neurologic assessment. 632 • Protective swallowing and gag reflexes are intact. • Vital signs are stable and consistent with baseline values for at least 30 min after the last dosing. Different health care institutions set different criteria that must be met and documented, with the child's vital signs being within 15% of admission readings— either above or below; Some use criteria of blood pressure and pulse rate within normal limits or within 20 points of baseline, temperature lower than 101° F (38.3° C); oxygen saturation is at least 95% on room air 30 min after the last dose. • Child must be ambulatory without assistance appropriate for his or her age and/or at baseline levels. • Child is able to ingest and retain oral fluids. • An adult is present to get the patient home and remain with the patient for at least two half-lives of the various drugs used for the anesthesia. NOTE: Drugs given as anesthesia for moderate sedation procedures are given only under controlled situations by anesthesia providers. Local anesthesia of specific peripheral nerves is accomplished by nerve block anesthesia or infiltration anesthesia. Nerve block anesthesia involves relatively deep injections of drugs into locations adjacent to major nerve trunks or ganglia. It focuses on a relatively large body region but not necessarily as extensive as that affected by spinal anesthesia. In contrast, infiltration anesthesia involves multiple small injections (intradermal, subcutaneous, submucosal, or intramuscular) to produce a more limited or “local” anesthetic field. Another subtype of local anesthesia involves topical application of a drug (e.g., lidocaine) onto the surface of the skin, mucous membranes, or eye. A new method of administering local anesthetics is via a peripheral nerve catheter attached to a pump containing the local anesthetic. These pumps are designed to infuse local anesthetic for several days postoperatively around the nerves that innervate the surgical site. The catheter is implanted during surgery and is normally taken out by the patient at home once the 633 anesthetic has been infused. Common trade names include Pain Buster and On-Q Pump. Mechanism of Action and Drug Effects Local anesthetics work by rendering a specific portion of the body insensitive to pain by interfering with nerve transmission. Nerve conduction is blocked only in the area where the anesthetic is applied, and there is no loss of consciousness. Local anesthetics block both the generation and conduction of impulses through all types of nerve fibers (autonomic, sensory, and motor) by blocking the movement of certain ions (sodium, potassium, and calcium) important to this process. Some of these drugs are also described as membrane-stabilizing because they alter the cell membrane of the nerve so that the free movement of ions is inhibited. The membrane-stabilizing effects occur first in the small fibers and then in the large fibers. In terms of paralysis, usually autonomic activity is affected first; then pain and other sensory functions are lost. Motor activity is the last to be lost. When the effects of the local anesthetic wear off, recovery occurs in reverse order: motor activity returns first, then sensory functions, and finally autonomic activity. Possible systemic effects of local anesthetics include effects on circulatory and respiratory function. The systemic adverse effects depend on where and how the drug is administered (e.g., injection at a certain level in the spinal cord or topical application of a drug that gains access to the circulation). Such adverse effects are unlikely unless large quantities of a drug are injected. Local anesthetics also produce sympathetic blockade; that is, they block the action of the two neurotransmitters of the sympathetic nervous system: norepinephrine and epinephrine (see Chapter 18). Indications Local anesthetics are used for surgical, dental, or diagnostic procedures as well as for the treatment of various types of chronic pain. Spinal anesthesia is used to control pain during surgical procedures and childbirth. Nerve block anesthesia is used for surgical, dental, and diagnostic procedures and for the therapeutic management of chronic pain. Infiltration anesthesia is used for 634 relatively minor surgical and dental procedures. Contraindications Contraindications for local anesthetics include known drug allergy. Only specially formulated dosage forms are intended for ophthalmic use (see Chapter 57). Adverse Effects The adverse effects of the local anesthetics are limited and of little clinical importance in most circumstances. The undesirable effects usually occur with high plasma concentrations of the drug, which result from inadvertent intravascular injection, an excessive dose or rate of injection, slow metabolic breakdown, or injection into a highly vascular tissue. One notable complication of spinal anesthesia is spinal headache. This occurs in up to 70% of patients who either experience inadvertent dural puncture during epidural anesthesia or undergo intrathecal anesthesia. Spinal headache is most often self-limiting and is treated with bed rest and conventional analgesic medications. Oral or intravenous forms of the CNS stimulant caffeine (see Chapter 13) are also sometimes used. Severe cases of spinal headache may be treated by the anesthetist by injecting a small volume (roughly 15 mL) of the patient's own venous blood into the patient's epidural space. The exact mechanism by which this blood patch provides relief is unknown, but it is effective in treating spinal headache in over 90% of cases. (See Box 11.9 for more information on spinal headaches.) True allergic reactions to local anesthetics are rare; however, they can occur, ranging from skin rash, urticaria, and edema to anaphylactic shock. Such allergic reactions are generally limited to a particular chemical class of anesthetics called the ester type. Box 11.3 categorizes the local anesthetic drugs into the ester and amide chemical families. A study tip to differentiate amides from ester local anesthetics is to remember that amides all have the letter “i” in their name before the suffix “-caine,” whereas esters do not. Knowing the different classes of local anesthetics is important, because patients who are allergic to an ester type may not be allergic to an amide type of local anesthetic. 635 Box 11.3 Chemical Groups of Local Anesthetics Ester Type benzocaine chloroprocaine cocaine procaine proparacaine propoxycaine tetracaine Amide Type bupivacaine dibucaine etidocaine lidocaine mepivacaine prilocaine Different enzymes are responsible for the breakdown of these two groups of anesthetics in the body. Anesthetics belonging to the ester family are metabolized by cholinesterase in the plasma and liver. They are converted into a para-aminobenzoic acid (PABA) compound. This compound is responsible for the allergic reactions. In contrast, the amide type of anesthetic is metabolized uneventfully to active and inactive metabolites in the liver by other enzymes. Often when an individual has an adverse reaction to one of the local anesthetics, using a drug from the alternate chemical class can avoid the problem. Toxicity and Management of Overdose Local anesthetics have little opportunity to cause toxicity under most circumstances. However, systemic reactions are possible if 636 sufficiently large quantities are absorbed into the systemic circulation. To prevent this from occurring, a vasoconstrictor such as epinephrine is often coadministered with the local anesthetic to maintain localized drug activity (e.g., lidocaine/epinephrine or bupivacaine/epinephrine). This property of epinephrine also serves to reduce local blood loss during minor surgical procedures. If significant amounts of the locally administered anesthetic are absorbed systemically, cardiovascular and respiratory function may be compromised. Interactions Few clinically significant drug interactions occur with the local anesthetics. When given with enflurane, halothane, or epinephrine, these drugs can lead to dysrhythmias. Drug Profiles Local anesthetics include lidocaine, bupivacaine, chloroprocaine, mepivacaine, prilocaine, procaine, propoxycaine, ropivacaine, and tetracaine. There are two major types of local anesthetics as determined by chemical structure: amides and esters (remember that all amides have the “i” located before the “-caine” and esters have no “i” before the “-caine”). lidocaine Lidocaine belongs to the amide class of local anesthetics. Some patients may report that they have allergic or anaphylactic reactions to the “caines,” as they may refer to lidocaine and the other amide drugs. In these situations, it may be wise to try a local anesthetic of the ester type. Lidocaine (Xylocaine) is one of the most commonly used local anesthetics. It is available in several strengths, both alone and in different concentrations with epinephrine; it is used for both infiltration and nerve block anesthesia. Lidocaine is also available in topical forms, including the unique EMLA, a cream mixture of lidocaine and prilocaine that is applied to skin to ease the pain of needle punctures (e.g., starting an intravenous line). There is also a 637 transdermal lidocaine patch for relief of postherpetic neuralgia. Parenteral lidocaine is also used to treat certain cardiac dysrhythmias as well as in the management of postoperative pain to decrease the use of systemic opioids. Contraindications include known drug allergy. Lidocaine is classified as a pregnancy category B drug. Neuromuscular Blocking Drugs NMBDs prevent nerve transmission in skeletal and smooth muscles, leading to paralysis. They are often used as adjuncts with general anesthetics for surgical procedures. NMBDs also paralyze the skeletal muscles required for breathing: the intercostal muscles and the diaphragm. The patient is rendered unable to breathe on his or her own, and mechanical ventilation is required to prevent brain damage or death from suffocation. Deaths have been reported when an NMBD is accidentally mistaken for a different drug and given to a patient who is not mechanically ventilated. Most hospitals have taken extra precautions to keep NMBDs separated from other drugs or have marked them with warning stickers. It is essential for the nurse to ensure that the patient is ventilated before giving an NMBD and to double-check that an NMBD is not inadvertently given. In the event of an error, the patient would experience a horrendous death, because the mind is alert but the patient cannot speak or move (see the box titled “Safety and Quality Improvement: Preventing Medication Errors”). Safety and Quality Improvement: Preventing Medication Errors Neuromuscular Blocking Drugs Neuromuscular blocking drugs (NMBDs) are considered high-alert drugs, because improper use may lead to severe injury or death. The Institute for Safe Medication Practices has reported several cases of patient death or injury as a result of medication errors 638 involving NMBDs. Because these drugs paralyze the respiratory muscles, incorrect administration without sufficient ventilator support has resulted in patient deaths. There have been medication errors due to “sound-alike” drug names as well (e.g., vancomycin and vecuronium). Most institutions have followed recommendations to restrict access to these drugs, provide warning labels and reminders, and increase staff awareness of the dangers of these drugs. For more information, visit www.ismp.org. Historically, snakes and plants have played a role in the discovery of substances that cause paralysis; the related receptor proteins in humans have also been studied. Curare is considered the grandfather of modern NMBDs. Several curare-like drugs are now used in clinical practice. The first drug to be used medicinally was d-tubocurarine, which was introduced into anesthesia practice in 1940; it has now been replaced by newer drugs. Mechanism of Action and Drug Effects NMBDs are classified into two groups based on mechanism of action: depolarizing and nondepolarizing. Depolarizing NMBDs work much like the neurotransmitter acetylcholine (ACh). They bind in place of ACh to cholinergic receptors at the motor endplates of muscle nerves or neuromuscular junctions. Thus they are competitive agonists (see Chapter 2). There are two phases of depolarizing block. During phase I (depolarizing phase), the muscles fasciculate (twitch). Eventually, after continued depolarization has occurred, muscles are no longer responsive to the ACh released; thus muscle tone cannot be maintained and the muscle becomes paralyzed. This is phase II, or the desensitizing phase. Succinylcholine is the only depolarizing NMBD. The duration of action of succinylcholine after a single dose is only 5 to 9 minutes because of its rapid breakdown by cholinesterase, the enzyme responsible for metabolizing succinylcholine. Nondepolarizing NMBDs also bind to ACh receptors at the neuromuscular junction, but instead of mimicking ACh, they block its actions. Therefore these drugs are competitive antagonists (see 639 Chapter 2) of ACh. Consequently the nerve cell membrane is not depolarized, the muscle fibers are not stimulated, and skeletal muscle contraction does not occur. Nondepolarizing NMBDs include cisatracurium, rocuronium, vecuronium, and pancuronium; they are typically classified into three groups based on their duration of action: short-acting, intermediate-acting, and longacting drugs. Cisatracurium has a unique biotransformation process. Most drugs are biotransformed in the liver and eliminated by the kidneys. Cisatracurium is broken down by Hoffman elimination, a process dependent on pH and temperature. This makes it the drug of choice for patients with end-stage renal disease. The typical time course of NMBD-induced paralysis during a surgical procedure is as follows: The first sensation that the patient typically feels is muscle weakness. This is usually followed by a total flaccid paralysis. Small, rapidly moving muscles such as those of the fingers and eyes are generally the first to be paralyzed. The next are those of the limbs, neck, and trunk. Finally, the intercostal muscles and the diaphragm are paralyzed, which causes respiratory arrest. Now the patient can no longer breathe on his or her own. It must be noted that NMBDs, when used alone, do not cause sedation or relieve pain or anxiety. Therefore the patient must also receive appropriate medications to manage pain and/or anxiety. Recovery of muscular activity after discontinuation of anesthesia usually occurs in the reverse order of the paralysis; thus the diaphragm is ordinarily the first to regain function. Indications The main therapeutic use of NMBDs is for maintaining skeletal muscle paralysis to facilitate controlled ventilation during surgical procedures. Shorter-acting NMBDs are often used to facilitate intubation with an endotracheal tube. This is commonly done for a variety of diagnostic procedures such as laryngoscopy and bronchoscopy or when the patient requires mechanical ventilation. When used for this purpose, NMBDs are frequently combined with anxiolytics, analgesics, and anesthetics. 640 Contraindications Contraindications to depolarizing NMBDs include known drug allergy and may also include previous history of malignant hyperthermia, penetrating eye injuries, and narrow-angle glaucoma, burns, recent cerebrovascular accident, and crush injuries. Adverse Effects The muscle paralysis induced by depolarizing NMBDs (e.g., succinylcholine) is sometimes preceded by muscle spasms, which may damage muscles. These muscle spasms are termed fasciculations and are most pronounced in the muscle groups of the hands, feet, and face. Injury to muscle cells may cause postoperative muscle pain and release potassium into the circulation, resulting in hyperkalemia. Hyperkalemia is the primary concern for the anesthesia provider. The nurse should make every effort to be aware of the patient's potassium status. Small doses of nondepolarizing NMBDs are sometimes administered with succinylcholine to minimize these muscle fasciculations. In spite of these disadvantages, succinylcholine is still popular due to its rapid onset of action, depth of neuromuscular blockade, and short duration of action. For these reasons, it is often preferred to nondepolarizing NMBDs for rapid-sequence induction of anesthesia (e.g., for emergency intubation). The effects on the cardiovascular system vary depending on the NMBD used and the individual patient. Some NMBDs cause a release of histamine, which can result in bronchospasm, hypotension, and excessive bronchial and salivary secretion. The gastrointestinal tract is seldom affected by NMBDs. When it is affected, decreased tone and motility typically result, which can lead to constipation or even ileus. Use of succinylcholine has been associated with hyperkalemia; dysrhythmias; fasciculations; muscle pain; myoglobinuria; increased intraocular, intragastric, and intracranial pressure; and malignant hyperthermia. The key to limiting adverse effects with most NMBDs is to use only enough of the drug to block the neuromuscular receptors. If too much is used, the risk that other ganglionic receptors will be 641 affected is increased. Blockade of these other ganglionic receptors leads to most of the undesirable effects of NMBDs. The effects of ganglionic blockade in various areas of the body are listed in Table 11.7. TABLE 11.7 Effects of Ganglionic Blockade by Neuromuscular Blocking Drugs Site Arterioles Veins Heart Gastrointestinal tract Urinary bladder Salivary glands Part of Nervous System Blocked Sympathetic Sympathetic Parasympathetic Parasympathetic Parasympathetic Parasympathetic Physiologic Effect Vasodilation and hypotension Dilation Tachycardia Reduced tone and motility; constipation Urinary retention Dry mouth Toxicity and Management of Overdose The primary concern when NMBDs are overdosed is prolonged paralysis requiring prolonged mechanical ventilation (see the box titled “Safety and Quality Improvement: Preventing Medication Errors”). Cardiovascular collapse may be seen and is thought to be the result of histamine release. Multiple medical conditions, listed in Box 11.4, can predispose an individual to toxicity because they increase his or her sensitivity to NMBDs and prolong their effects. Some conditions make it more difficult for NMBDs to work, thus requiring the use of higher doses. These conditions, listed in Box 11.5, do not necessarily lead to toxicity or overdose. Box 11.4 Conditions That Predispose Patients to Toxic Effects From Neuromuscular Blocking Drugs Acidosis 642 Hypocalcemia Hypokalemia Hypothermia Myasthenia gravis Neonatal status Paraplegia Box 11.5 Conditions That Oppose the Effects of Neuromuscular Blocking Drugs Cirrhosis with ascites Clostridial infections Hemiplegia Hypercalcemia Hyperkalemia Peripheral nerve transection Peripheral neuropathies Thermal burns Anticholinesterase drugs such as neostigmine, pyridostigmine, and edrophonium are antidotes for nondepolarizing NMBDs such as vecuronium, rocuronium, and cistatricurium. Anticholinesterase drugs work by preventing the enzyme cholinesterase from breaking down ACh. This causes ACh to build up at the motor endplate, where it eventually displaces the nondepolarizing NMBD molecule, returning the nerve to its original state. However, succinylcholine is not reversed with acetylcholinesterase inhibitors because of its short duration of action and natural breakdown. Sugammadex (Bridion) is a new selective relaxant binding agent used for the reversal of rocuronium or vecuronium. Malignant hyperthermia, which is a dysmetabolic syndrome, (see the section titled “General Anesthetics” earlier in the chapter) can also occur with succinylcholine. Dosages Selected Neuromuscular Blocking Drugs 643 Pharmacologic Class rocuronium Nondepolarizing (Zemuron) NMBD (intermediateacting) succinylcholine Depolarizing NMBD (Anectine, (short-acting) Quelicin) Drug Usual Adult Dosage Range IV: 0.6–1.2 mg/kg Continuous infusion: 0.8–12 mcg/kg/min IV: 0.3–1.1 mg/kg IM: 3–4 mg/kg Indications/Uses Intubation, mechanical ventilation Intubation NMBD, Neuromuscular blocking drug. Interactions Many drugs interact with NMBDs, which may lead to either synergistic or opposing effects. When given with an NMBD, aminoglycoside antibiotics can have additive effects. The tetracycline antibiotics can also produce neuromuscular blockade, possibly by chelation of calcium, and calcium channel blockers have also been shown to enhance neuromuscular blockade. Other notable drugs that interact with NMBDs are listed in Box 11.6. Box 11.6 Drugs That Interact With Neuromuscular Blocking Drugs Additive Effects aminoglycosides calcium channel blockers clindamycin cyclophosphamide cyclosporine dantrolene furosemide inhalation anesthetics local anesthetics magnesium 644 quinidine Opposing Effects carbamazepine corticosteroids phenytoin Dosages For dosage information of selected NMBDs, see the table below. Drug Profiles NMBDs are among the most commonly used classes of drugs in the operating room. They are given primarily with general anesthetics to facilitate endotracheal intubation and to relax skeletal muscles during surgery. In addition to their use in the operating room, they are given in the ICU to paralyze mechanically ventilated patients. There are two basic types of NMBDs: depolarizing and nondepolarizing drugs. Nondepolarizing NMBDs are generally classified by their duration of action. Box 11.7 lists examples of currently used nondepolarizing drugs. Box 11.7 Classification of Nondepolarizing Neuromuscular Blocking Drugs Intermediate-Acting Drugs atracurium (Tracrium) cisatracurium (Nimbex) rocuronium (Zemuron) vecuronium (Norcuron) Long-Acting Drugs 645 pancuronium (Pavulon) Depolarizing Neuromuscular Blocking Drugs succinylcholine Succinylcholine is the only currently available drug in the depolarizing subclass of NMBDs. Succinylcholine (Anectine, Quelicin) has a structure similar to that of the parasympathetic neurotransmitter Ach. It stimulates the same neurons as ACh and produces the same physiologic responses initially. Compared with ACh, however, succinylcholine is metabolized more slowly. Because of this slower metabolism, succinylcholine subjects the motor endplate to ongoing depolarizing stimulation. Repolarization cannot occur. As long as sufficient succinylcholine concentrations are present, the muscle loses its ability to contract, and flaccid muscle paralysis results. Because of its quick onset of action, succinylcholine is most commonly used to facilitate endotracheal intubation. It is seldom used over long periods because of its tendency to cause muscular fasciculations. It is contraindicated in patients with a personal or familial history of malignant hyperthermia, skeletal muscle myopathies, and known hypersensitivity to the drug. It is available only in injectable form. For dosage information, see the table on the previous page. Pharmacokinetics: Succinylcholine Route Onset of Action IV Rapid, less than 1 min Peak Plasma Concentration 60 sec Elimination Half-Life Less than 1 min Duration of Action 4–6 min Nondepolarizing Neuromuscular Blocking Drugs Nondepolarizing NMBDs are commonly used to facilitate endotracheal intubation, reduce muscle contraction, and facilitate a variety of diagnostic procedures. They are often combined with anxiolytics or anesthetics and may also be used to induce respiratory arrest in patients on mechanical ventilation. 646 rocuronium Rocuronium (Zemuron) is a rapid- to intermediate-acting nondepolarizing NMBD. It is used as an adjunct to general anesthesia to facilitate tracheal intubation and provide skeletal muscle relaxation during surgery or mechanical ventilation. Use of rocuronium is contraindicated in cases of known drug allergy. It is available only in injectable form. For dosage information, see the table on the previous page. Pharmacokinetics: Rocuronium Route IV Onset of Action 1–2 min Peak Plasma Concentration 4 min Elimination Half- Duration of Life Action 50–144 min 30 min Teamwork and Collaboration: Pharmacokinetic Bridge to Nursing Practice With moderate (conscious or procedural) sedation or anesthesia, it is always important to understand the pharmacokinetic properties of the drug or drugs used. For example, the intravenous form of midazolam has an onset of action of 1 to 5 minutes, a peak plasma effect of 20 to 60 minutes, an elimination half-life of 1 to 4 hours (the time it takes for 50% of the drug to be excreted), and a duration of action of 2 to 6 hours. Therefore if midazolam is used for moderate sedation, you will begin to see the sedating properties within 1 to 5 minutes and peak effects on the patient between 20 to 60 minutes. Since the drug's action lasts for only 2 to 6 hours, midazolam is an attractive option for use in outpatient procedures because of its fast onset and short duration of action. Therefore as noted with regard to this drug's pharmacokinetic properties, you may be able to predict the drug's onset of action, peak effect, and duration of action. Nursing Process Assessment 647 It is important to note that anesthetics are not drugs that are typically given by the registered nurse unless the nurse is an anesthesia provider. Exceptions to this statement are orders for topical forms, such as oral swish-and-swallow solutions that may be used during chemotherapy and lidocaine patches for pain relief. Associated with each drug used for general and local anesthesia are some very broad as well as specific assessment parameters. First, for any form of anesthesia and during any of the phases of anesthesia, the major parameters to assess are airway, breathing, and circulation (ABCs). Include in your assessment questions regarding allergies and use of prescription as well as over-thecounter drugs, herbals, supplements, and social and/or illegal drugs. Another important area to assess is the patient's use of alcohol and nicotine. Excessive use of alcohol may alter the patient's response to general anesthesia. If an individual has become tolerant to the effects of alcohol, he or she may typically be more tolerant to anesthetic medication. Also, if the patient has a history of alcohol abuse, withdrawal symptoms generally do not occur in the perioperative period. The critical time frame for this type of patient will be when he or she has been without alcohol for a couple of days in the postoperative period and is no longer receiving sedation or analgesics. Perform a respiratory assessment (e.g., respiratory rate, rhythm, and depth; breath sounds; oxygen saturation level), especially if the patient has a history of smoking or is currently a smoker. The patient's history of smoking is important because nicotine has a paralyzing effect on the cilia within the respiratory tract. Once they are malfunctioning, these cilia cannot perform their main role of keeping foreign bodies out of the lungs and allowing mucus and secretions to be coughed up with ease. Malfunctioning of the cilia can potentially lead to atelectasis or pneumonia. Other objective data include weight and height, because these parameters are often used in the dosing of anesthesia. Further studies that may be ordered by the anesthesia provider and/or surgeon include an electrocardiogram, chest radiograph, and tests of renal function (e.g., BUN level, creatinine level, urinalysis with specific gravity) and hepatic function (e.g., total protein and albumin levels; bilirubin level; ALP, AST, and ALT levels). Additional laboratory 648 tests may include Hgb, Hct, WBC with differential, and tests that indicate clotting abilities, such as PT-INR), aPTT, and platelet count. Also to be assessed are results for serum electrolytes—specifically potassium, sodium, chloride, phosphorus, magnesium, and calcium —because abnormalities may lead to further complications from the anesthesia. You must assess the results of a pregnancy test, if ordered, in females of childbearing age because of the possibility of teratogenic effects (adverse effects on the fetus) related to the anesthetic drug. Case Study Patient-Centered Care: Moderate (Conscious) Sedation © Vgstudio. A 53-year-old woman is scheduled to have a colonoscopy this morning, and she is very anxious. The anesthesia provider has explained the moderate (conscious) sedation that is planned, but the patient says, after the anesthetist leaves the room, “I'm so afraid of feeling it during the test. Why don't they just put me to sleep?” 1. How does moderate sedation differ from general anesthesia? 2. What is the nurse's best answer to the patient's question? 3. What is important for the nurse to assess before this procedure is performed? The anesthesia provider prepares to administer morphine and midazolam (Versed) before the procedure. 4. Explain the purpose of these two medications during 649 moderate sedation. How are the dosages adjusted when these drugs are given together? Neurologic assessment includes a thorough survey of the patient's mental status. Determine and document level of consciousness, alertness, and orientation to person, place, and time prior to the anesthesia. Additional neurologic assessment includes motor assessments, with left-right and upper extremity versus lower extremity comparisons of strength, reflexes, grasp, and ability to move on command. Sensory assessment focuses on the same anatomic areas, with comparisons of the response to various types of stimuli such as sharp, dull, soft, and cold versus warm. Swallowing ability and gag reflexes are also important to assess and document for baseline status and comparisons. When these motor, sensory, and cognitive parameters are within normal limits, there is proof of an intact neurologic system. One very significant reaction to assess in patients receiving general anesthesia is that of malignant hyperthermia. This is a rapid progression of hyperthermia that may be fatal if not promptly recognized and aggressively treated. The tendency is inherited, so questions about related signs and symptoms in the family's and patient's medical histories are important to document and report. A familial history of malignant hyperthermia would put the patient at risk. Signs and symptoms of malignant hyperthermia include a rapid rise in body temperature, tachycardia, tachypnea, muscle rigidity, cyanosis, irregular heartbeat, mottling of the skin, diaphoresis (profuse sweating), and an unstable blood pressure. If there is no documented problem with general anesthesia or the patient is undergoing general anesthesia for the first time, perform an astute and careful examination of all medical and medication histories. With any type of anesthesia, it is often a very slight change in vital signs, other vital parameters, and laboratory test results that may provide nursing and other health care providers with a possible clue to the patient's reaction to anesthesia. Note that malignant hyperthermia occurs during the anesthesia process and in the surgical suite; nevertheless, close observation after anesthesia is still important and much needed. Intravenously administered anesthetic drugs are usually combined with adjuvant drugs (given 650 at the same time), such as sedative-hypnotics, antianxiety drugs, opioid and nonopioid analgesics, antiemetics, and anticholinergics. These drugs are used to decrease some of the undesirable after effects of inhaled anesthetics. If they are used, perform a complete assessment for each of the drugs, including obtaining a medical history and medication profile. Hepatic and renal function studies are important in these patients as well, so that any risks of toxicity and complications can be anticipated. For patients about to undergo anesthesia with neuromuscular blocking drugs (NMBDs), perform a complete head-to-toe assessment with a thorough medical and medication history. Which specific drug is being used and whether it is depolarizing or nondepolarizing will guide your assessment, because of the action of NMBDs on the patient's neuromuscular functioning (see earlier in this chapter). Assess all cautions, contraindications, and drug interactions. Another concern with the use of these drugs is that they are associated with an increase in intraocular and intracranial pressure. Therefore these anesthetic drugs should not be used or used only with extreme caution (close monitoring of these pressures) in patients with glaucoma or closed head injuries. Complete a thorough respiratory assessment in patients receiving NMBDs because of the effect of these drugs on the respiratory system. In particular, these drugs have a paralyzing effect on the muscles used for breathing and—for this very reason—are used to facilitate intubation for mechanical ventilation. Paralysis of respiratory muscles allows patient relaxation to the point where the patient will not fight against the breaths delivered by the ventilator. Also indicated with the use of NMBDs is careful assessment of serum electrolyte levels, specifically potassium and magnesium levels. Imbalances in these electrolytes may lead to increased action of the NMBD, with exacerbation of the drug's actions and toxic effects. Allergic reactions to these drugs are most commonly characterized by rash, fever, respiratory distress, and pruritus. Drug interactions with herbal products are outlined in the box Safety: Herbal Therapies and Dietary Supplements on the next page. For more specific information on the differences between depolarizing and nondepolarizing NMBDs, see the Drug Profiles. 651 Safety: Herbal Therapies and Dietary Supplements Possible Effects of Herbal Products When Combined With Anesthetics Feverfew: Migraine headaches, insomnia, anxiety, joint stiffness, increased risk for bleeding Garlic: Changes in blood pressure, risk for increased bleeding Ginger: Sedating effects; risk for bleeding, especially if taken with either aspirin or ginkgo Ginseng: Irritability and insomnia, risk for cardiac adverse effects Kava: Sedating effects, potential liver toxicity, risk for additive effects with medications St. John's Wort: Sedation, blood pressure changes For more information, visit www.aana.com, www.abc.herbalgram.com, and www.nccih.nih.gov. With the use of conscious or moderate sedation, as with any anesthesia technique, assessment for allergies, cautions, contraindications, and drug interactions is important. Because moderate sedation is commonly used across the lifespan, closely assess organ function and note diseases or conditions that could lead to excessive levels of the drug in the body, such as liver or kidney impairment. See Chapters 10 and 12 for more information about the assessment associated with the use of opioids and sedative-hypnotics/CNS depressants. Use of spinal anesthesia requires thorough assessment with an emphasis on the ABCs, respiratory function, and vital signs, specifically blood pressure. Baseline respirations with attention to rate, rhythm, depth, and breath sounds are important to note, as are oxygen saturation levels obtained via pulse oximetry. Because of possible problems with vasodilatation from the spinal anesthetic, document baseline blood pressure levels and pulse rate. Record 652 history of previous reactions to this form of anesthesia, allergies, a listing of all medications, and report any abnormal reactions to the anesthesia provider and surgeon. Neurologic assessment with notation of sensory and motor intactness in the lower extremities as well as documentation of any abnormalities is important. The use of epidural anesthesia requires special attention to overall hemostasis through monitoring of vital signs and levels of oxygen saturation. Assess baseline sensory and motor function in the extremities and document an intact neurologic system (see “Implementation,” further on, for a more detailed discussion). Spinal headaches may occur with either spinal anesthesia or epidural injections, and thus baseline assessment for the presence of headaches is important. Local-topical anesthetics, such as lidocaine, used for either infiltration or nerve block anesthesia may be administered with or without a vasoconstrictor (e.g., epinephrine). The vasoconstrictors are used to help confine the local anesthetic to the injected area, prevent systemic absorption of the anesthetic, and reduce bleeding. If there is systemic absorption of the vasoconstrictor into the bloodstream, the patient's blood pressure could rise to lifethreatening levels, especially in those who are at high risk (e.g., owing to underlying arterial disease). Therefore review the patient's medical history to assess for any preexisting illnesses—such as vascular disease, aneurysms, or hypertension—because these may be contraindications to the use of the vasoconstrictor with the anesthetic. In addition, with these local anesthetics, assess for allergies to the drug as well as baseline vital signs. Also assess for possible drug interactions, and note prescription medications, herbal products, supplements, and over-the-counter medications. In summary, it is important with any type of anesthesia to assess the patient's level of homeostasis prior to actual administration of the drug. This assessment may include taking vital signs as well as checking the ABCs. Other parameters of interest may be oxygen saturation levels measured by pulse oximetry, cardiovascular and respiratory function, and neurologic function. Human Need Statements 1. Altered oxygenation, decreased gas exchange, related to the 653 general anesthetic's CNS depressant effect with altered respiratory rate and effort (decreased rate, decreased depth) 2. Altered oxygenation, decreased cardiac output, related to the systemic effects of anesthesia 3. Freedom from pain, acute, related to the adverse effect of spinal headache from epidural anesthesia 4. Altered autonomous choice with lack of knowledge/ related to lack of information about anesthesia 5. Altered safety needs, risk for injury, related to the impact of any form of anesthesia on the CNS (e.g., CNS depression, decreased sensorium) Planning: Outcome Identification 1. Patient is able to explain methods used to increase respiratory expansion through coughing, deep breathing, turning, and ambulating (when allowed). 2. Patient remains well hydrated with increase in fluids and remains ambulating to help increase circulation and minimize complications, unless contraindicated. 3. Patient states measures to help minimize and/or prevent acute pain from possible complication of spinal headache with bed rest, hydration, and following postanesthesia/postepidural orders for up to 24 to 48 hours after procedure. 4. Patient experiences maximal effects of anesthesia as noted by following preanesthesia orders, such as remaining NPO, taking medications only as prescribed, as well as experiencing minimal adverse effects from an adequate knowledge about the postanesthesia period and ways to minimize problems (see all measures listed in outcome criteria 1 to 3 and 5). 5. Patient remains free from injury and/or falls by asking for assistance while ambulating or having assistance if at home and recovering alone as well as taking medications only as prescribed, sitting up for brief periods prior to ambulating, forcing fluids, and resuming adequate nutritional intake during the postanesthesia period. 654 Implementation Regardless of the type of anesthesia used, one of the most important nursing considerations during the preanesthesia, intraanesthesia, and postanesthesia periods is close and frequent observation of all body systems. Begin with a focus on the ABCs of nursing care, vital signs, and oxygen saturation levels as measured by pulse oximetry as well as by the clinical presentation of the patient. Remember that the way a patient looks is very important at any point in time! Document the observations from these interventions, and repeat the interventions as needed, depending on the patient's status and in keeping with the standard of care for the type of anesthesia. Monitor vital signs frequently, as needed, and based on the patient's condition, including assessing the fifth vital sign of pain (see discussion later in this section and in Chapter 10). With general anesthesia, it is especially important to assess the patient's temperature because of the risk for malignant hyperthermia, and close monitoring is required if malignant hyperthermia occurred during the anesthesia process. This sudden elevation in the patient's body temperature (e.g., higher than 104°F [40°C]) not only requires critical care during and immediately after anesthesia but also calls for close monitoring even during regular postoperative care (see earlier discussion). When intravenous, inhaled, or other forms of anesthesia are used, resuscitative equipment and medications, including opioid antidotes, must be readily available in the surgical and postsurgical areas in case of cardiorespiratory distress or arrest. The anesthesia provider keeps control of the anesthetic drug, and he or she will be well prepared for any emergency—as is the entire group of individuals in the surgical suite and postanesthesia recovery area. Continual monitoring of the status of breath sounds is an important intervention, because hypoventilation may be a complication of general and other forms of anesthesia. Oxygen is administered after a patient has received general and/or other forms of anesthesia to compensate for the respiratory depression that may have occurred during the anesthesia and surgical process. Because oxygen is considered a drug, a prescriber's order is needed for its administration. Continuous monitoring of oxygen saturation levels is therefore an important intervention. In addition, hypotension and 655 orthostatic hypotension are possible problems after anesthesia; thus postural blood pressure measurements (supine and standing), in addition to regular blood pressure monitoring, may be needed. Additional nursing interventions include monitoring of neurologic parameters such as reflexes, response to commands, level of consciousness or sedation, and pupillary reaction to light. It is also necessary to monitor for changes in sensation and movement in the extremities, distal pulses, temperature, and color when nerve blocks and spinal anesthesia are used because it is important to confirm that areas distal to the anesthetic site have remained intact. If the patient requires pain management once the anesthesia has been terminated, remember that the anesthetic and any adjuvant drugs used continue to have an effect on the patient until the period of the drugs' action has passed. Therefore sedative-hypnotics, opioids, nonopioids, and other CNS depressants for pain relief must be administered cautiously and only with close monitoring of vital signs. If the patient has received some of these medications during postanesthesia, document dosages of drugs used and then pass them on in a report when the patient is transferred to another unit. Additional orders are usually provided by the physician/surgeon or anesthesia provider regarding doses of analgesics to administer once the patient has been transferred or discharged to home. If such orders have not been provided, however, and the patient is experiencing pain, contact the appropriate prescriber. The concern here is that the patient may receive either too much or not enough analgesic. Patients who receive NMBDs as part of an induction process for mechanical ventilation must be monitored closely during and after initiation of mechanical ventilation. Patients receiving NMBDs and who are awake may need to receive other medications for sedation and/or pain. These patients are in intensive care or critical care units, and many protocols are provided regarding interventions after the intubation. These include measurement of vital signs and determination of neurologic status, including sensation and handgrasp strength. When mechanical ventilation is used, educate patients and family members about the purpose of the druginduced paralysis during mechanical ventilation (e.g., to prevent the patient from fighting against the ventilation provided by the 656 machine, resisting the effects of the mechanical ventilatory assistance, and possibly causing him or her to hypoventilate). Inform the family and remind those involved in the nursing care of such a patient that he or she can still hear the spoken word. Knowing what to expect is key to helping decrease fear and anxiety —for both the patient and those visiting the patient. Patients undergoing moderate sedation as the method of anesthesia should receive patient education before the procedure. As noted earlier in the chapter, recovery from this type of anesthesia is more rapid, and the safety profile is better than that of general anesthesia, with its inherent cardiorespiratory risks. As with general anesthesia, however, monitor the ABCs, vital signs, pulse oximetry oxygen saturation levels, and level of consciousness or sedation. Box 11.8 provides more information on moderate sedation. Box 11.8 Moderate or Conscious Sedation: What to Expect and Questions to Ask 1. What questions should the patient or caregiver ask about the technique of moderate or conscious sedation? • Who will be providing this type of anesthesia? • Who will be monitoring me or my loved one? • Will there be constant monitoring of blood pressure, pulse rate, respiratory rate, and temperature? • Will there be emergency equipment in the room in case of need? • Are the personnel qualified to administer these drugs? To administer advanced cardiac life support? • What do I need to know about care at home? Will I need help? Can I drive after having the procedure? 2. What are the adverse effects of moderate or conscious sedation? • Brief periods of amnesia (loss of memory) • Headache • Hangover feeling 657 • Nausea and vomiting 3. What is to be expected immediately following the procedure? • Frequent monitoring • Written postoperative instructions and care • If the patient is of driving age, no driving for at least 24 hours after moderate sedation • A follow-up contact by phone to check on the patient 4. Who administers the conscious sedation? • Moderate or conscious sedation is safe when administered by qualified providers. Anesthesia providers, other physicians, dentists, and oral surgeons are qualified to administer conscious sedation. 5. Which procedures generally require moderate sedation? • Breast biopsy • Vasectomy • Minor foot surgery • Minor bone fracture repair • Plastic or reconstructive surgery • Dental prosthetic or reconstructive surgery • Endoscopy (such as diagnostic studies and treatment of stomach, colon, and bladder cancer) 6. What are the overall benefits of this type of anesthesia? • It is a safe and effective option for patients undergoing minor surgeries or diagnostic procedures. • It allows patients to recover quickly and resume normal activities in a relatively short period of time. 7. Are there any concerns about daily medications or herbals if undergoing conscious sedation? • As with any form of anesthesia, being open and honest with the anesthesia provider is of significant importance to patient safety. • Be sure to follow instructions closely regarding the intake of all medications including herbals, food, or liquids before anesthesia as such substances may react negatively with the drugs being administered. • Inquire about any brochures or written pamphlets such as the American Association of Nurse Anesthetists (AANA) brochure titled “Before anesthesia: Your 658 active role makes a difference.” Data from Council for Public Interest in Anesthesia. Conscious sedation: What patients should expect. Patient Pamphlet. Available at www.aana.com. Accessed March 31, 2015. Publication date unavailable. With spinal anesthesia, nursing interventions must include constant monitoring for a return of sensation and motor activity below the anesthetic insertion site. Because of the risk that the anesthetic drug may move upward in the spinal cord and breathing may be affected, continually monitor respiratory and breathing status. In addition, because positioning is important to the movement of the anesthetic drug, keep the head of the bed elevated. Remember, though, that this complication is usually identified and treated by the anesthesia provider, and patients will not return to their rooms on a nursing unit until all respiratory risks have been identified and managed appropriately. Another major area of concern with spinal anesthesia is the risk for a sudden decrease in blood pressure. This drop in blood pressure is secondary to vasodilation caused by the anesthetic block to the sympathetic vasomotor nerves. Vital signs and oxygen saturation levels should return to normal before the patient is transferred out of postanesthesia care; however, these vital signs must still be monitored frequently after transfer. Another adverse reaction to neuraxial or central anesthesia is the occurrence of spinal headaches. These may occur with both intrathecal and epidural injections but are actually more frequent with the latter. Because intrathecal spinal needle designs have been technologically improved, the occurrence of spinal headaches is rare. Larger-bore needles are used to deliver epidural anesthetics; however, and these are more likely to give rise to spinal headache if they are inadvertently passed through the dura mater (the covering of the spinal cord). Keep the patient hydrated and on bed rest as recommended by the anesthesia provider. Box 11.9 offers more information about these headaches and their treatment. Box 11.9 659 Spinal Headaches: A Brief Look at a Terrible Pain Why do spinal headaches occur? As a result of penetration into and through the dura mater of the spinal cord (the covering of the spinal cord), a leakage of cerebrospinal fluid occurs from the insertion site. If enough of the spinal fluid leaks out, a spinal headache results. These headaches are more likely to be associated with epidural anesthesia than with intrathecal anesthesia because of the larger needles used with epidurals. What are the symptoms of a spinal headache? Patients say that these headaches are worse than any other type. They are more severe when the patient is in an upright position and improve on lying down. They may occur up to 5 days after the procedure and may be prevented with bed rest after the epidural procedure. How are spinal headaches treated? Adequate hydration using intravenous fluids is often tried to help increase cerebral spinal fluid pressure. Other recommendations include the drinking of a beverage high in caffeine and strict bed rest for 24 to 48 hours. If the headaches are intolerable, however, the anesthesia provider may create a “blood patch” to help close up or seal the leak. This requires insertion of a needle into the same space or right next to the area that was injected with the anesthesia. A small amount of blood is then taken from the patient and injected into the epidural space. The blood clots and forms a seal over the hole that caused the leak, and the headache is relieved. Data from the American Association of Nurse Anesthetists. (2005). Conscious sedation: what patients should expect. Available at www.aana.com; Bezov, D., Ashina, S., & Lipton, R. (2010). Post-dural puncture headache: part II—prevention, management, and prognosis. Headache, 50(9), 1482–1498. The use of epidural anesthesia (also called regional anesthesia in some textbooks) does not pose the same risk of respiratory complications as general anesthesia; however, monitoring is still needed to confirm overall homeostasis. You must measure vital signs and pulse oximetry to determine oxygen saturation levels. In addition, patients undergoing this form of anesthesia require 660 monitoring for the return of motor function and tactile sensation. Check the patient frequently for the return of sensation bilaterally along the dermatome (area of the skin innervated by specific segments of the spinal cord); such monitoring is important to ensure patient safety as well as to maximize comfort. Assess touch sensation through hand pressure or a gentle pinch of the skin. You need to know the level at which the epidural anesthesia was given to monitor properly for return of sensation. This monitoring process generally occurs in a PACU, and the patient is not returned to a regular nursing unit until all sensation and/or voluntary movement of the lower extremities is regained. With regard to the use of topical or local anesthetics (e.g., lidocaine with or without epinephrine), solutions that are not clear and appear cloudy or discolored are not to be used. Some anesthesia providers mix the solution with sodium bicarbonate to minimize local pain during infiltration, but this also causes a more rapid onset of action and a longer duration of sensory analgesia. If an anesthetic ointment or cream is used, the nurse will thoroughly cleanse and dry the area to be anesthetized before applying the drug. If a topical or local anesthetic is being used in the nose or throat, remember that it may cause paralysis and/or numbness of the structures of the upper respiratory tract, which can lead to aspiration. If the patient receives a solution form of anesthetic, exact amounts of the drug are used and at the exact dosing times or intervals. Local anesthetics are not to be swallowed unless the prescriber has so instructed. Should this occur, closely observe the patient, check for the gag reflex, and expect to withhold food or drink until the patient's sensation and/or gag reflex has returned. Once the patient has recovered from the anesthesia as well as the procedure and is ready for discharge, complete your patient teaching. Focus patient education on the patient's needs and how these needs can be met at home. Home health care and/or rehabilitation services may be indicated, and arrangements should be made before the patient is discharged. If additional care or resources are needed at home (e.g., for a patient who lives alone), these arrangements should be completed in a timely fashion. Some examples of procedures for which help might be needed are wound care, dressing changes, surgical site care, drawing of blood for 661 laboratory studies, and administration of various medications through the intravenous, intramuscular, or subcutaneous route. Some patients may also need assistance with taking oral medications at home. Pain management requires thorough and individualized patient teaching and also includes any necessary education for patients who will require home health care. See Chapter 10 for more information on analgesics. Provide simple instructions using age-appropriate teaching strategies (see Chapter 6). Sharing of information about community resources is also important, especially for patients who need transportation, assistance with meals, housekeeping during recovery, and/or the services of additional health care providers (e.g., physical therapists, occupational therapists) in the home setting. Some of these community resources may be agencies that are supported by city or state social service programs. Meals on Wheels, senior citizen support groups, and church-sponsored groups are just a few examples of important resource groups. Many of these resources are free or have income-based fees. Additional suggestions regarding patient education are provided under “Patient-Centered Care: Patient Teaching,” further on. Evaluation The therapeutic effects of any general or local anesthesia include the following: loss of consciousness and reflexes during general anesthesia and loss of sensation to a particular area during local anesthesia (e.g., loss of sensation to the eye during corneal transplantation). Constantly monitor the patient who has undergone general anesthesia for the occurrence of adverse effects of the anesthesia. These may include myocardial depression, convulsions, respiratory depression, allergic rhinitis, and decreased renal or liver function. Constantly monitor patients who have received a local anesthetic for the occurrence of adverse effects, including bradycardia, myocardial depression, hypotension, and dysrhythmias. In addition, as mentioned earlier in this chapter, significant overdoses of local anesthetic drugs or direct injection into a blood vessel may result in cardiovascular collapse or cardiac or respiratory depression. For those receiving spinal anesthesia, 662 therapeutic effects include loss of sensation below the area of administration; adverse effects include hypotension, hypoventilation, urinary retention, the possibility of a prolonged period of decreased sensation or motor ability, and infection at the site. With epidural or intrathecal anesthesia, therapeutic effects are similar and adverse effects include loss of motor function or sensation below the area of administration. Spinal headaches may occur with epidural or spinal anesthesia. Moderate sedation provides the therapeutic effect of a decreased sensorium but without the complications of general anesthesia; however, there are CNS depressant effects associated with the drugs used. Patient-Centered Care: Patient Teaching • Whenever general anesthesia is used, emphasize the prescriber's recommendations/orders about whether any medications should be discontinued or tapered before anesthetic administration. • Make sure information about the anesthetic, route of administration, adverse effects, and special precautions is included in preprocedure and surgical education. • Openly discuss with the patient all fears and anxieties about anesthesia and related procedures/surgery. • Share with the patient and family instructions about the postanesthesia process and the need for close monitoring of vital signs, breath sounds, and neurologic intactness. Patients should expect frequent turning, coughing, and deep breathing to prevent atelectasis or pneumonia. • Encourage patients to ambulate with assistance as needed and as ordered. Mobility helps increase circulation and improves ventilation to the alveoli of the lungs; consequently circulation to the legs will be improved (which helps to prevent stasis of blood and possible blood clot formation in the leg veins). Assistance is needed to prevent falls or injury until the patient has recovered from the anesthetic. • Encourage the patient to request pain medication, if needed, 663 before pain becomes moderate to severe. Inform the patient that even though anesthesia has been administered, there may still be discomfort or pain from the procedure or surgery. The anesthesia will wear off, and adequate analgesia will be needed. Ask the patient to rate his or her pain on a scale of 0 to 10, with 0 being no pain and 10 being the worst possible pain. See Chapter 10 for more information on pain assessment and its management. • Explain the rationale for any other treatments or procedures related to the anesthesia (e.g., epidural catheter placement; delivery of oxygen; administration of a gas; use of various tubes, catheters, or intravenous lines). Adequate patient education will help ease fears and anxieties and help in preventing adverse effects or complications. • For a patient with diminished sensorium, the bed side rails need to be moved in the up position and a call button placed at the bedside. These actions are critical to patient safety. Note that bed alarms may be used. Everyone involved in the postanesthesia and postsurgical care (e.g., family members) must be educated about these safety measures. • With local anesthesia, the patient needs to have a thorough understanding of the purpose, action, and adverse effects of the specific local anesthetic agent. • Inform a patient receiving spinal anesthesia about the need for frequent assessments, measurement of vital signs, and system assessments during and after the procedure. Key Points • Anesthesia is the loss of the ability to feel pain resulting from the administration of an anesthetic drug. General anesthesia is a drug-induced state in which the nerve impulses of the CNS are altered to reduce pain and other sensations throughout the entire body and normally involves 664 complete loss of consciousness and respiratory drive depression. • General anesthetics are drugs that induce general anesthesia, including the administration of specific parenteral anesthetics. Inhalational anesthetic drugs are also general anesthetics and include volatile liquids or gases. • Local anesthetics are used to induce a state in which peripheral or spinal nerve impulses are altered to reduce or eliminate pain and other sensations. Spinal anesthesia, or regional anesthesia, is a form of local anesthesia. • Conscious or moderate sedation is a form of general anesthesia resulting in partial or complete loss of consciousness but without reducing normal respiratory drive. • Adjunct anesthetics are drugs that assist with the induction of general anesthesia and include NMBDs, sedative-hypnotics, and/or anxiolytics and antiemetics. • Nondepolarizing NMBDs are used as an adjunct to general anesthesia to provide skeletal muscle relaxation during surgery and/or mechanical ventilation. • Nursing assessment is very important to patient safety during and after all forms of anesthesia. With general anesthesia, however, one major problem to be concerned with is that of malignant hyperthermia, which may be fatal if not promptly recognized and aggressively treated. Signs and 665 symptoms include rapid rise in body temperature, increased pulse rate (tachycardia)/respiratory rate (tachypnea), muscle rigidity, and unstable blood pressure. Critical Thinking Exercises 1. The nurse is assessing a patient who had hip replacement surgery 2 hours earlier and has just arrived to the orthopedic unit from the PACU. The certified nursing assistant reports that the patient's temperature is 104.8°F (40.4°C). The nurse notes that the PACU nurse reported that the patient's temperature was 98.9°F (37.2°C) just before leaving the PACU. Another nurse comments that the patient must be developing an infection from the hip replacement. What is the nurse's priority action at this time? 2. The nurse is assessing a patient who is receiving mechanical ventilation because of respiratory problems. The nurse tells the patient's wife that he is receiving medication to keep him relaxed and allow the ventilator to work. The patient's wife asks the nurse, “Is he awake? Can he hear me?” What is the nurse's best answer? Review Questions 1. The physician has requested “lidocaine with epinephrine.” The nurse recognizes that the most important reason for adding epinephrine is which of these factors? a. It helps to calm the patient before the procedure. b. It minimizes the risk for an allergic reaction. 666 c. It enhances the effect of the local lidocaine. d. It reduces bleeding in the surgical area. 2. The surgical nurse is reviewing operative cases scheduled for the day. Which of these patients is more prone to complications from general anesthesia? (Select all that apply.) a. A 79-year-old woman who is about to have hip replacement surgery b. A 49-year-old male athlete who quit heavy smoking 12 years ago c. A 19-year-old male who has a history of substance and alcohol abuse d. A 30-year-old woman who is in perfect health but has never had anesthesia e. A 50-year-old woman scheduled for outpatient laser surgery for vision correction 3. Which human need statement is appropriate for a patient who is now recovering after having been under general anesthesia for 3 to 4 hours during surgery? a. Altered urinary elimination, decreased, related to the use of vasopressors as anesthetics b. Decreased self control related to the effects of general anesthesia c. Altered safety with risk for falls related to decreased sensorium for 2 to 4 days postoperatively d. Altered oxygenation, decreased, due to the CNS depressant effect of general anesthesia 4. A patient is recovering from general anesthesia. What is the nurse's main concern during the immediate postoperative period? 667 a. Airway b. Pupillary reflexes c. Return of sensations d. Level of consciousness 5. A patient is about to undergo cardioversion, and the nurse is reviewing the procedure and explaining moderate sedation with propofol. The patient asks, “I am afraid of feeling it when they shock me.” What is the nurse's best response? a. “You won't receive enough of a shock to feel anything.” b. “You will feel the shock but you won't remember any of the pain.” c. “These medications will help ease any pain during the procedure, and many patients often report having no recollection of the procedure.” d. “They will give you enough pain medication to prevent you from feeling it.” 6. The nurse is administering an NMBD to a patient during a surgical procedure. Number the following phases of muscle paralysis in the order in which the patient will experience them. (Number 1 is the first step.) a. Paralysis of intercostals and diaphragm muscles b. Muscle weakness c. Paralysis of muscles of the limbs, neck, and trunk d. Paralysis of small rapidly moving muscles (fingers, eye) 7. During a patient's recovery from a lengthy surgery, the nurse monitors for signs of malignant hyperthermia. In addition to a rapid rise in body temperature, which 668 assessment findings would indicate the possible presence of this condition? (Select all that apply.) a. Respiratory depression b. Tachypnea c. Tachycardia d. Seizure activity e. Muscle rigidity 8. A patient will be receiving diazepam (Valium), 2 mg, IV push as part of preprocedure sedation. The medication is available in an injectable solution of 5 mg/mL. How many milliliters will the nurse give for this dose? References Chang W. Pediatric sedation. [Available at] http://emedicine.medscape.com/article/804045overview [Updated June 27, 2016]. Desai A, Macario A. Anesthesia, general. [Available at] http://emedicine.medscape.com/article/1271543overview. Gan TJ, Diemunsch P, Habib AS, et al. Consensus guidelines for the management of postoperative nausea and vomiting. Anesthesia & Analgesia. 2014;118:85. Petro-Yura H, Walsh MB. Human needs 2 and the nursing process. Catholic University of America Press: Washington, DC; 1983. Prabhakar H, Singh GP, Ali Z, et al. Pharmacological and non-pharmacological interventions for reducing rocuronium bromide induced pain on injection in children and adults. Cochrane Database of Systematic Reviews. 2016;(2) [CD009346]. 669 Press CD. General anesthesia. [Updated November 30, 2015; Available at] http://emedicine.medscape.com/article/1271543overview. Reddy JI, Cooke PJ, van Schalkwyk JM, et al. Anaphylaxis is more common with rocuronium and succinylcholine than with atracurium. Anesthesiology. 2015;122:39. 670 12 Central Nervous System Depressants and Muscle Relaxants OBJECTIVES When you reach the end of this chapter, you will be able to do the following: 1. Briefly describe the functions of the central nervous system. 2. Contrast the effects of central nervous system depressant drugs and central nervous system stimulant drugs (see Chapter 13) as relates to their basic actions. 3. Define the terms hypnotic, rapid eye movement, rapid eye movement sleep interference, rapid eye movement rebound, sedative, sedativehypnotic, sleep, and therapeutic index. 4. Briefly discuss the problem of sleep disorders. 5. Identify the specific drugs within each of the following categories of central nervous system depressant drugs: benzodiazepines, nonbenzodiazepines, muscle relaxants, orexin receptor antagonists, and miscellaneous drugs. 6. Contrast the mechanism of action, indications, adverse effects, toxic effects, cautions, contraindications, dosage forms, routes of 671 administration, and drug interactions of the following medications: benzodiazepines, nonbenzodiazepines, muscle relaxants, orexin receptor antagonists, and miscellaneous drugs. 7. Discuss the nursing process as it relates to the nursing care of a patient receiving any central nervous system depressants and/or muscle relaxants. 8. Develop a thorough nursing care plan related to the use of pharmacologic and nonpharmacologic approaches to the treatment of sleep disorders. KEY TERMS Barbiturates A class of drugs used to induce sedation; chemical derivatives of barbituric acid. Benzodiazepines A chemical category of drugs most frequently prescribed as anxiolytic drugs and less frequently as sedativehypnotic agents. Gamma-aminobutyric acid (GABA) The primary inhibitory neurotransmitter found in the brain. A key compound affected by sedative, anxiolytic, psychotropic, and muscle-relaxing medications. Hypnotics Drugs that, when given at low to moderate dosages, calm or soothe the central nervous system without inducing sleep but when given at high dosages cause sleep. Non–rapid eye movement (non-REM) sleep The largest portion of the sleep cycle. It has four stages and precedes REM sleep. Rapid eye movement (REM) sleep One of the stages of the sleep cycle. Some of the characteristics of REM sleep are rapid movement of the eyes, vivid dreams, and irregular breathing. REM interference A drug-induced reduction of REM sleep time. REM rebound Excessive REM sleep following discontinuation of a 672 sleep-altering drug. Sedatives Drugs that have an inhibitory effect on the central nervous system to the degree that they reduce nervousness, excitability, and irritability without causing sleep. Sedative-hypnotics Drugs that can act in the body either as sedatives or as hypnotics. Sleep A transient, reversible, and periodic state of rest in which there is a decrease in physical activity and consciousness. Sleep architecture The structure of the various elements involved in the sleep cycle, including normal and abnormal patterns of sleep. Therapeutic index The ratio between the toxic and therapeutic concentrations of a drug. If the index is low, the difference between the therapeutic and toxic drug concentrations is small and use of the drug is more hazardous. Drug Profiles baclofen, p. 191 cyclobenzaprine, p. 191 diazepam, p. 187 eszopiclone, p. 188 midazolam, p. 187 pentobarbital, p. 190 phenobarbital, p. 190 ramelteon, p. 188 suvorexant, p. 188 temazepam, p. 187 zolpidem, p. 188 High-Alert Drug 673 midazolam, p. 187 Overview Sedatives and hypnotics are drugs that have a calming effect or that depress the central nervous system (CNS). A drug is classified as either a sedative or a hypnotic drug, depending on the degree to which it inhibits the transmission of nerve impulses to the CNS. Sedatives reduce nervousness, excitability, and irritability without causing sleep, but a sedative can become a hypnotic if it is given in large enough doses. Hypnotics cause sleep and have a much more potent effect on the CNS than do sedatives. Many drugs can act as either a sedative or a hypnotic, depending on dose and patient responsiveness, and for this reason are called sedative-hypnotics. Sedative-hypnotics can be classified chemically into three main groups: barbiturates, benzodiazepines, and miscellaneous drugs. Physiology of Sleep Sleep is defined as a transient, reversible, and periodic state of rest in which there is a decrease in physical activity and consciousness. Normal sleep is cyclic and repetitive, and a person's responses to sensory stimuli are markedly reduced during sleep. During our waking hours, the body is constantly bombarded with stimuli provoking the senses of sight, hearing, touch, smell, and taste. Involuntary and voluntary movements or functions are elicited, but stimuli no longer are part of our awareness during sleep. Sleep research involves study of the patterns of sleep, or what is sometimes referred to as sleep architecture. The architecture of sleep consists of two basic elements that occur cyclically: rapid eye movement (REM) sleep and non–rapid eye movement (non-REM) sleep. The normal cyclic progression of the stages of sleep is summarized in Table 12.1. Various sedative-hypnotic drugs affect different stages of the normal sleep pattern. Prolonged sedativehypnotic use may reduce the cumulative amount of REM sleep; this is known as REM interference. This can result in daytime fatigue because REM sleep provides a certain component of the “restfulness” of sleep. Upon discontinuance of a sedative-hypnotic 674 drug, REM rebound can occur, in which the patient has an abnormally large amount of REM sleep, often leading to frequent and vivid dreams. Abuse and misuse of sedative-hypnotic drugs is common and is discussed in Chapter 17. TABLE 12.1 Stages of Sleep Average Percentage of Sleep Time in Stages (for Young Adult) Stage Characteristics Non-REM Sleep 1 Dozing or feelings of drifting off to sleep; person can be easily awakened; slow, side-to-side eye movements; insomniacs have longer stage 1 periods than normal. 2 Sleep deepening and a higher arousal threshold being required to awaken the patient. 3 Deep sleep; difficult to wake person; respiratory rates, pulse, and blood pressure may decrease; stages 3 and 4 often combined and referred to as “delta sleep” or “slowwave sleep”; delta sleep associated with the highest arousal threshold. 4 Very difficult to wake person; person may be very groggy if awakened; dreaming occurs, especially about daily events; sleepwalking or bedwetting may occur. REM Sleep REMs occur; vivid dreams occur; breathing may be irregular. 2%–5% 45%–55% 3%–8% 10%–15% 25%–33% NOTE: Four to five cycles are completed during normal sleep for adults. Non-REM sleep constitutes approximately the first third of the night, and REM sleep is more prominent during the last third of the night. REM, Rapid eye movement. Modified from Urden, L. D., Stacy, K. M., & Lough, M. E. (2014). Priorities in critical care nursing (7th ed.). St. Louis: Mosby. Patient-Centered Care: Cultural Implications 675 Understanding Your Patient's Sleep Needs • When questioning your patient about his or her usual sleep patterns and habits, always consider cultural influences on the promotion of sleep. • Collect a thorough health, medication, and diet history to identify food, spices, and/or supplements or herbal practices used to manage common everyday problems, such as insomnia. • Asians, Pacific Islanders, Hispanics, and African Americans have a high incidence of lactose intolerance, so use of warm milk at bedtime to help with sleep may lead to gastrointestinal (GI) distress, abdominal cramping, and bloating. Lactose-free milk may be used. • Some Asian Americans believe in the yin and the yang and may practice meditation, herbology, nutritional interventions, and acupuncture for sleep. • Chinese patients have been found to require lower doses of the drug class of benzodiazepines including diazepam (Valium) and alprazolam (Xanax). • Some Hispanics believe that maintaining a balance in diet and physical activity are methods for preventing evil or poor health. Nondrug therapies and/or home remedies of vegetables and herbs may be used for sleep and other health issues. • Jewish Americans may tend to be less accepting of therapeutic touch as compared with some cultures. Nurses must be sensitive to this and find alternatives to massage. Benzodiazepines and Miscellaneous Hypnotic Drugs Historically, benzodiazepines were the most commonly prescribed sedative-hypnotic drugs; however, the nonbenzodiazepine drugs are now more frequently prescribed. Other drugs commonly used for sleep include diphenhydramine (see Chapter 36), trazodone, and amitriptyline (see Chapter 16). The benzodiazepines show 676 favorable adverse effect profiles, efficacy, and safety when used appropriately. Benzodiazepines are classified as either sedativehypnotics or anxiolytics, depending on their primary use. Anxiolytic drugs are used to reduce the intensity of feelings of anxiety. However, any of these drugs can function along a continuum as a sedative and/or hypnotic and/or anxiolytic, depending on the dosage and patient sensitivity. See Chapter 16 for a further discussion of the anxiolytic use of benzodiazepines. There are five benzodiazepines commonly used as sedative-hypnotic drugs. In addition, there are several miscellaneous drugs that are used as hypnotics. They function much like benzodiazepines but are chemically distinct from them and are listed in Table 12.2. Ramelteon is a hypnotic drug not related to any other hypnotics. It has a new mechanism of action and is profiled separately later in the chapter. The newest drugs for insomnia include suvorexant (Belsomra) and tasimelteon (Hetlioz). Suvorexant is the first in a new class of drugs called selective oxrexin receptor antagonists. Orexins are neuropeptides involved in the regulation of the sleepwake cycle. Suvorexant is profiled later in this chapter. Tasimelteon is indicated only for disturbances of sleep-wake cycle in patients who are totally blind and, due to its limited use, will not be discussed further in this textbook. TABLE 12.2 Sedative-Hypnotic Benzodiazepines and Miscellaneous Drugs Generic Name Long Acting clonazepam diazepam flurazepam Intermediate Acting alprazolam lorazepam suvorexant temazepam Short Acting eszopiclonea midazolam Trade Name Klonopin Valium Dalmane Xanax Ativan Belsomra Restoril Lunesta Versed 677 ramelteona triazolam zaleplona diazolpidema Rozerem Halcion Sonata Ambien a These drugs share many characteristics with the benzodiazepines but are classified as miscellaneous hypnotic drugs. Mechanism of Action and Drug Effects The sedative and hypnotic action of benzodiazepines is related to their ability to depress activity in the CNS. The specific areas that are affected include the hypothalamic, thalamic, and limbic systems of the brain. Although the mechanism of action is not certain, research suggests that there are specific receptors in the brain for benzodiazepines. These receptors are thought to be either gammaaminobutyric acid (GABA) receptors or other adjacent receptors. GABA is the primary inhibitory neurotransmitter of the brain, and it serves to modulate CNS activity by inhibiting overstimulation. Like GABA itself, benzodiazepine activity appears to be related to their ability to inhibit stimulation of the brain. Indications Benzodiazepines have a variety of therapeutic applications. They are commonly used for sedation, relief of agitation or anxiety, treatment of anxiety-related depression, sleep induction, skeletal muscle relaxation, and treatment of acute seizure disorders. Benzodiazepines are often combined with anesthetics, analgesics, and neuromuscular blocking drugs in balanced anesthesia and also moderate sedation (see Chapter 11) for their amnesic properties to reduce memory of painful procedures. Finally, benzodiazepine receptors in the CNS are in the same area as those that play a role in alcohol addiction. Therefore some benzodiazepines (e.g., diazepam, chlordiazepoxide) are used in the treatment and prevention of the symptoms of alcohol withdrawal (see Chapter 17). When benzodiazepines are used to treat insomnia, it is recommended that they be used short term, if clinically feasible, to avoid dependency. 678 Contraindications Contraindications to the use of benzodiazepines include known drug allergy, narrow-angle glaucoma, and pregnancy. Adverse Effects As a class, benzodiazepines have a relatively favorable adverse effect profile; however, they can be harmful if given in excessive doses or when mixed with alcohol. Adverse effects associated with their use usually involve the CNS. Commonly reported undesirable effects are headache, drowsiness, paradoxical excitement or nervousness, dizziness or vertigo, cognitive impairment, and lethargy. Benzodiazepines can create a significant fall hazard in older adults, and the lowest effective dose must be used in this patient population. Although these drugs have comparatively less intense effects on the normal sleep cycle, a “hangover” effect is sometimes reported (e.g., daytime sleepiness). Withdrawal symptoms such as rebound insomnia (i.e., greater insomnia than pretreatment) may occur with abrupt discontinuation. Toxicity and Management of Overdose An overdose of benzodiazepines may result in one or all of the following symptoms: somnolence, confusion, diminished reflexes, and coma. Overdose of benzodiazepines alone rarely results in hypotension and respiratory depression. These effects are more commonly seen when benzodiazepines are taken with other CNS depressants such as alcohol or barbiturates. In the absence of the concurrent ingestion of alcohol or other CNS depressants, benzodiazepine overdose rarely results in death. Treatment of benzodiazepine intoxication is generally symptomatic and supportive. Flumazenil, a benzodiazepine antidote, can be used to acutely reverse the sedative effects of benzodiazepines. It antagonizes the action of benzodiazepines on the CNS by directly competing with the benzodiazepine for binding at the receptors. Flumazenil is used in cases of oral overdose or excessive intravenous sedation. The dosage regimens to be followed for the reversal of conscious sedation or general anesthesia induced 679 by benzodiazepines and the management of suspected overdoses are summarized in Table 12.3. TABLE 12.3 Flumazenil Treatment Regimen Indication Reversal of moderate sedation or general anesthesia Management of suspected benzodiazepine overdose Recommended Regimen 0.2 mg (2 mL) IV over 15 sec, then 0.2 mg if consciousness does not occur; may be repeated at 60sec intervals prn up to 4 additional times (maximum total dose, 1 mg) Duration 1–4 hr 0.2 mg (2 mL) IV over 30 sec; wait 30 sec, then give 0.3 mg (3 mL) over 30 sec if consciousness does not occur; further doses of 0.5 mg (5 mL) can be given over 30 sec at intervals of 1 min up to a cumulative dose of 3 mg 1–4 hr NOTE: Flumazenil has a relatively short half-life and a duration of effect of 1 to 4 hours; therefore if flumazenil is used to reverse the effects of a longacting benzodiazepine, the dose of the reversal drug may wear off and the patient may become sedated again, requiring more flumazenil. Interactions Potential drug interactions with the benzodiazepines are significant because of their intensity, particularly when they involve other CNS depressants (e.g., alcohol, opioids, muscle relaxants). These drugs result in further CNS depressant effects, including reduced blood pressure, reduced respiratory rate, sedation, confusion, and diminished reflexes. This and other major drug interactions are listed in Table 12.4. Herbal supplements that interact with the benzodiazepines include kava and valerian, which may also lead to further CNS depression. Food-drug interactions include interactions with grapefruit and grapefruit juice, which alter drug metabolism via inhibition of the cytochrome P-450 system and can result in prolonged effect, increased effect, and toxicity. In 2016 the US Food and Drug Administration (FDA) issued a black box warning for all opioids and all benzodiazepines regarding the risk of combined use. The combination should be used only if no other alternatives are available. Risks include extreme sleepiness, respiratory depression, coma, and death. 680 TABLE 12.4 Benzodiazepines: Drug/Food Interactions Drug Azole antifungals, verapamil, diltiazem, protease inhibitors, macrolide antibiotics, grapefruit juice CNS depressants Mechanism Decreased benzodiazepine metabolism Additive effects olanzapine Unknown rifampin Increased metabolism Result Prolonged benzodiazepine action Increased CNS depression Increased benzodiazepine effects Decreased benzodiazepine effects CNS, Central nervous system. Dosages For dosage information, see the table on the next page. Drug Profiles Benzodiazepines and miscellaneous sedative-hypnotic drugs are prescription-only drugs, and they are designated as schedule IV controlled substances. Uses for benzodiazepines can vary. Safety: Herbal Therapies and Dietary Supplements Kava (Piper methysticum) Overview Kava consists of the dried rhizomes of Piper methysticum. The drug contains kava pyrones (kawain). Extended continuous intake can cause a temporary yellow discoloration of the skin, hair, and nails. Common Uses 681 Relief of anxiety, stress, restlessness; promotion of sleep Adverse Effects Skin discoloration, possible accommodative disturbances and pupillary enlargement, scaly skin (with long-term use) Potential Drug Interactions Alcohol, barbiturates, psychoactive drugs Contraindications Contraindicated in patients with Parkinson disease, liver disease, depression, or alcoholism; in those operating heavy machinery; and in pregnant and breastfeeding women Safety: Herbal Therapies and Dietary Supplements Valerian (Valeriana officinalis) Overview Valerian root, consisting of fresh underground plant parts, contains essential oil with monoterpenes and sesquiterpenes (valerianic acids). Common Uses Relief of anxiety, restlessness, sleep disorders Adverse Effects Central nervous system depression, hepatotoxicity, nausea, vomiting, anorexia, headache, restlessness, insomnia Potential Drug Interactions Central nervous system depressants, monoamine oxidase inhibitors, phenytoin; may have enhanced relative and adverse effects when taken with other drugs (including other herbal products) that have known sedative properties (including alcohol) Contraindications 682 Contraindicated in patients with cardiac disease, liver disease, or those operating heavy machinery including treatment of insomnia, moderate sedation (see Chapter 11), muscle relaxation, anticonvulsant therapy (see Chapter 14), and anxiety relief (see Chapter 16). The miscellaneous drugs are normally used only for their hypnotic purposes to treat insomnia. Dosage information appears in the dosages table on this page. Benzodiazepines diazepam Diazepam (Valium) was the first clinically available benzodiazepine drug; as such, it is the prototypical benzodiazepine. It has varied uses, including treatment of anxiety, Dosages Selected Benzodiazepine and Other Sedative-Hypnotic Drugs Drug Usual Adult Onset and (Pregnancy Dosage Duration Category) Range diazepam Long acting PO: 2–10 (Valium) (D) mg 3–4 times daily IV: 2–10 mg eszopiclonea Short acting PO: 1–3 mg at bedtime (Lunesta) (C) ramelteona Short acting PO: 8 mg at bedtime (Rozerem) (C) suvorexanta Long acting PO: 10–20 mg at bedtime (Belsomra) (C) temazepam Intermediate PO: 7.5–30 mg (Restoril) (D) acting at bedtime zaleplon Short acting PO: 5–10 mg (Sonata)a (C) at bedtime zolpidema Short acting PO: 5-10 mg at bedtime (Ambien) (C) 683 Indications/Uses Muscle relaxation, preprocedure sedation, status epilepticus, acute anxiety/agitation Sleep induction Sleep induction Sleep induction Sleep induction Sleep induction Sleep induction a Nonbenzodiazepine drugs. procedural sedation and anesthesia adjunct, anticonvulsant therapy, and skeletal muscle relaxation following orthopedic injury or surgery. It is available in oral, rectal, and injectable forms. Pharmacokinetics: Diazepam Route IV PO Onset of Action Immediate 30 min Peak Plasma Concentration 8 min 1–2 hr Elimination HalfLife 20–50 hr 20–60 hr Duration of Action 15–60 min 12–24 hr midazolam Midazolam (Versed) is most commonly used preoperatively and for moderate sedation. It is useful for this indication due to its ability to cause amnesia and anxiolysis (reduced anxiety) as well as sedation. The drug is normally given by injection in adults. However, a liquid oral dosage form is also available for children. See Chapter 11 for dosage information. Pharmacokinetics: Midazolam Route IV Onset of Action 1–5 min Peak Plasma Concentration 20–60 min Elimination Half- Duration of Life Action 1–4 hr 2–6 hr temazepam Temazepam (Restoril), an intermediate-acting benzodiazepine, is actually one of the metabolites of diazepam and normally induces sleep within 20 to 40 minutes. Temazepam has a long onset of action, so it is recommended that patients take it approximately 1 hour prior to going to bed. Although it is still an effective hypnotic, it has been replaced by the newer drugs. Pharmacokinetics: Temazepam Route PO Onset of Action 30–60 min Peak Plasma Concentration 2–3 hr Elimination Half- Duration of Life Action 9.5–12 hr 7–8 hr 684 Nonbenzodiazepines eszopiclone Eszopiclone (Lunesta) is the first hypnotic to be FDA approved for long-term use. It is designed to provide a full 8 hours of sleep. It is considered a short- to intermediate-acting agent. As with other hypnotics, patients should allot 8 hours of sleep time and should avoid taking hypnotics when they must awaken in less than 6 to 8 hours. Pharmacokinetics: Eszopiclone Route PO Onset of Action 30–60 min Peak Plasma Concentration 1 hr Elimination Half- Duration of Life Action 6 hr 8 hr ramelteon Ramelteon (Rozerem) is structurally similar to the hormone melatonin, which is believed to regulate circadian rhythms (daynight sleep cycles) in the body. Over-the-counter dietary supplements containing melatonin have been available for several years. Ramelteon works as an agonist at melatonin receptors in the CNS. Technically it is not a CNS depressant, but it is included here because of its use as a hypnotic. It is also not classified as a controlled substance because of its lack of observed dependency risk. It has a shorter duration of action than do other hypnotics and is therefore indicated primarily for patients who have difficulty with sleep onset rather than sleep maintenance. Its use is contraindicated in cases of severe liver dysfunction. It is best avoided in patients receiving fluconazole or ketoconazole (see Chapter 42), both of which can impede its metabolism. Rifampin (see Chapter 41) can reduce the efficacy of ramelteon by speeding its metabolism via the induction of hepatic enzymes. Pharmacokinetics: Ramelteon Route PO Onset of Action 30–60 min Peak Plasma Concentration 45 min Elimination Half- Duration of Life Action 1–2.5 hr 6–8 hr 685 zolpidem Zolpidem (Ambien) is a short-acting nonbenzodiazepine hypnotic. Its short half-life and its lack of active metabolites contribute to a lower incidence of daytime sleepiness compared with benzodiazepine hypnotics; however, the FDA now recommends doses of 5 mg as a maximum dose for women or 5 to 10 mg for men, due to risk for next-morning impairment after its use. A unique dosage form, Ambien CR, is a longer-acting form with two separate drug reservoirs. One releases zolpidem faster than the other to induce hypnosis (sleep) more rapidly. The second reservoir also releases zolpidem but does so more slowly throughout the night to help maintain sleep. One special concern with this particular dosage form is the possibility of somnambulation, or sleepwalking, which has been reported with its use. Nevertheless, Ambien CR is currently one of only two hypnotics to be FDA approved for long-term use; the other is eszopiclone (Lunesta). Pharmacokinetics: Zolpidem Route PO Onset of Action 30 min Peak Plasma Concentration 1.6 hr Elimination Half- Duration of Life Action 1.4–4.5 hr 6–8 hr Orexin Receptor Antagonists Orexins, also referred to as hypocretins, are neuropeptides that have been shown to regulate transitions between wakefulness and sleep by promoting cholinergic/monoaminergic neural pathways. Orexin antagonists compete with the physiologic effects of orexin. Currently, suvorexant is the only orexin receptor antagonist available. suvorexant Suvorexant (Belsomra) is the first drug in a new class, called orexin receptor antagonists. Orexin A and orexin B are hypothalamic neuropeptides that play a key role in promoting wakefulness and regulating the sleep-wake cycle. Suvorexant is an oral dual orexin receptor antagonist with a 12-hour half-life. Adverse effects include 686 drowsiness, headache, dizziness, diarrhea, dry mouth, increased serum cholesterol, and cough. Many of the adverse effects are more common in females. Because suvorexant has a half-life of 12 hours, and there are safety concerns regarding daytime somnolence and unconscious nighttime behaviors. Suvorexant is a schedule IV drug. Pharmacokinetics: Suvorexant Route PO Onset of Action 30 min Peak Plasma Concentration 2 hr Elimination Half- Duration of Life Action 12 hr 12 hr Barbiturates Barbiturates were first introduced into clinical use in 1903 and were the standard drugs for treating insomnia and producing sedation. Chemically they are derivatives of barbituric acid. Although 50 different barbiturates are approved for clinical use in the United States, only a few are currently in clinical use. This is due to the favorable safety profile and proven efficacy of the benzodiazepines. Barbiturates can produce many unwanted adverse effects. They are physiologically habit forming and have a low therapeutic index. Barbiturates can be classified into four groups based on their onset and duration of action. Table 12.5 lists the barbiturates in each category and summarizes their pharmacokinetic characteristics. TABLE 12.5 Sedative-Hypnotic Barbiturates Generic Name Ultrashort Acting methohexital thiopental Short Acting pentobarbital secobarbital Intermediate Acting butabarbital Long Acting phenobarbital Trade Name Brevital Pentothal Nembutal Seconal Butisol Generic 687 mephobarbital Mebaral Mechanism of Action and Drug Effects Barbiturates are CNS depressants that act primarily on the brainstem in an area called the reticular formation. Their sedative and hypnotic effects are dose related, and they act by reducing the nerve impulses traveling to the area of the brain called the cerebral cortex. Their ability to inhibit nerve impulse transmission is due in part to their ability to potentiate the action of the inhibitory neurotransmitter GABA, which is found in high concentrations in the CNS. Barbiturates also raise the seizure threshold and can be used to treat seizures (see Chapter 14). Indications All barbiturates have the same sedative-hypnotic effects but differ in their potency, time to onset of action, and duration of action. It is important to note that the use of barbiturates is no longer recommended for sleep induction. The various categories of barbiturates can be used for the following therapeutic purposes: (1) ultrashort acting: anesthesia for short surgical procedures, anesthesia induction, control of convulsions, and reduction of intracranial pressure in neurosurgical patients; (2) short acting: sedation and control of convulsive conditions; (3) intermediate acting: sedation and control of convulsive conditions; and (4) long acting: epileptic seizure prophylaxis. Contraindications Contraindications to barbiturate use include known drug allergy, pregnancy, significant respiratory difficulties, and severe kidney or liver disease. These drugs must be used with caution in older adults due to their sedative properties and increased fall risk. Adverse Effects Adverse effects of barbiturates relate to the CNS and include drowsiness, lethargy, dizziness, hangover, and paradoxical 688 restlessness or excitement. Their long-term effects on normal sleep architecture can be detrimental. Barbiturates deprive people of REM sleep, which can result in agitation. When any barbiturate is stopped, a rebound phenomenon may occur. During this rebound, the proportion of REM sleep is increased and nightmares often ensue. Common adverse effects of barbiturates are listed in Table 12.6. As is the case with most sedative drugs, barbiturates are associated with an increased incidence of falls when used in older adults. If they are recommended for older adults at all, the usual dose is reduced by half whenever possible. TABLE 12.6 Barbiturates: Adverse Effects Body System Cardiovascular Gastrointestinal Hematologic Nervous Respiratory Other Adverse Effects Vasodilation and hypotension, especially if given too rapidly Nausea, vomiting, diarrhea, constipation Agranulocytosis, thrombocytopenia Drowsiness, lethargy, vertigo Respiratory depression, cough Hypersensitivity reactions: urticaria, angioedema, rash, fever, Stevens-Johnson syndrome Toxicity and Management of Overdose Treatment of an overdose is mainly symptomatic and supportive. The mainstays of therapy are maintenance of an adequate airway, assisted ventilation, and oxygen administration if needed, along with fluid and pressor support as indicated. Activated charcoal may be given; however, recent clinical data do not support its use because no improvement in clinical outcome has been shown. Phenobarbital and mephobarbital are relatively acidic and can be eliminated more quickly by the kidneys when the urine is alkalized (pH is raised). This keeps the drug in the urine and prevents it from being resorbed back into the circulation. Alkalization, along with forced diuresis using diuretics (e.g., furosemide [see Chapter 28]), can hasten elimination of the barbiturate. Interactions 689 Barbiturates as a class are notorious enzyme inducers. They stimulate the action of enzymes in the liver that are responsible for the metabolism or breakdown of many drugs. By stimulating the action of these enzymes, they cause many drugs to be metabolized more quickly, which usually shortens their duration of action. Barbiturates increase the activity of hepatic microsomal or cytochrome P-450 enzymes (see Chapter 2). This process is called enzyme induction. Induction of this enzyme system results in increased drug metabolism and breakdown. However, if two drugs are competing for the same enzyme system, the result can be inhibited drug metabolism and possibly increased toxicity for the wide variety of drugs that are metabolized by these enzymes. Other drugs that are enzyme inducers are rifampin and phenytoin. Additive CNS depression occurs with the coadministration of barbiturates with alcohol, antihistamines, benzodiazepines, opioids, and tranquilizers. Drugs most likely to have marked interactions with the barbiturates include monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants (see Chapter 16), anticoagulants (see Chapter 26), glucocorticoids (see Chapter 30), and oral contraceptives (see Chapter 34) with barbiturates. Coadministration of MAOIs and barbiturates can result in prolonged barbiturate effects. Coadministration of anticoagulants with barbiturates can result in decreased anticoagulation response and possible clot formation. Coadministration of barbiturates with oral contraceptives can result in accelerated metabolism of the contraceptive drug and possible unintended pregnancy. Women taking both types of medication concurrently need to be advised to consider an additional method of contraception as a backup. Dosages Barbiturates can act as either sedatives or hypnotics, depending on the dosage. For information on selected barbiturates and their recommended sedative and hypnotic dosages, see the following table. Dosages Selected Barbiturates 690 Drug pentobarbital (Nembutal) phenobarbital Onset and Duration Short acting Long acting Usual Dosage Adult Range IM: 150–200 mg IV: 100 mg PO: 30–120 mg/day divided IM/IV: 100–200 mg 60–90 min before surgery Indications/Uses Preoperative sedative Sedative Preoperative sedative Drug Profiles Like benzodiazepines, barbiturates can also have varied uses, including preoperative sedation, anesthesia adjunct, and anticonvulsant therapy. All barbiturates are controlled substances, but not all are on the same schedule, as illustrated in Table 12.7. Dosage information appears in the dosages table for barbiturates. TABLE 12.7 Barbiturates: Controlled Substance Schedule Schedule C-II C-III C-IV Barbiturates pentobarbital, secobarbital butabarbital, thiopental mephobarbital, methohexital, phenobarbital pentobarbital Pentobarbital (Nembutal) is a short-acting barbiturate. Formerly prescribed as a sedative-hypnotic for insomnia, pentobarbital is now principally used preoperatively to relieve anxiety and provide sedation. In addition, it is used occasionally to control status epilepticus. Pentobarbital may also be used to treat withdrawal symptoms in patients who are physically dependent on barbiturates or nonbarbiturate hypnotics. It is available in oral, injectable, and rectal dosage forms. Pharmacokinetics: Pentobarbital Route PO Onset of Action 30–60 min Peak plasma Concentration 1–2 hr Elimination Half- Duration of Life Action 20–45 min 3–4 hr 691 phenobarbital Phenobarbital is considered the prototypical barbiturate and is classified as a long-acting drug. Phenobarbital is used for the prevention of generalized tonic-clonic seizures and fever-induced convulsions. In addition, it has been useful in the treatment of hyperbilirubinemia in neonates. Currently it is only rarely used as a sedative and is no longer recommended to be used as a hypnotic drug. It is available in oral and injectable forms. Pharmacokinetics: Phenobarbital Route IV PO Onset of Action 5 min 30 min Peak Plasma Concentration 30 min 1–6 hr Elimination HalfLife 50–120 hr 50–120 hr Duration of Action 6–12 hr 6–12 hr Over-the-Counter Hypnotics Nonprescription sleeping aids often contain antihistamines (see Chapter 36). These drugs have a CNS depressant effect. The most common antihistamines contained in over-the-counter sleeping aids are doxylamine (Unisom) and diphenhydramine (Sominex). Analgesics (e.g., acetaminophen [see Chapter 10]) are sometimes added to offer some pain relief if pain is a component of the sleep disturbance (e.g., acetaminophen/diphenhydramine [Extra Strength Tylenol PM]). As with other CNS depressants, concurrent use of alcohol can cause additive CNS depression. Muscle Relaxants A variety of conditions such as trauma, inflammation, anxiety, and pain can be associated with acute muscle spasms. The muscle relaxants are a group of compounds that act predominantly within the CNS to relieve pain associated with skeletal muscle spasms. Most muscle relaxants are known as centrally acting skeletal muscle relaxants because their site of action is the CNS. Centrally acting skeletal muscle relaxants are similar in structure and action to other CNS depressants such as diazepam. It is believed that the muscle 692 relaxant effects are related to this CNS depressant activity. Only one of these compounds, dantrolene, acts directly on skeletal muscle. It belongs to a group of relaxants known as direct-acting skeletal muscle relaxants. It closely resembles GABA. Mechanism of Action and Drug Effects The majority of the muscle relaxants work within the CNS. Their beneficial effects are believed to come from their sedative effects rather than from direct muscle relaxation. Dantrolene acts directly on the excitation-contraction coupling of muscle fibers and not at the level of the CNS. It directly affects skeletal muscles by decreasing the response of the muscle to stimuli. It appears to exert its action by decreasing the amount of calcium released from storage sites in the sarcoplasmic reticula of muscle fibers. All other muscle relaxants have no direct effects on muscles, nerve conduction, or muscle-nerve junctions and have a depressant effect on the CNS. Their effects are the result of CNS depression in the brain primarily at the level of the brainstem, thalamus, and basal ganglia and also at the spinal cord. The effects of muscle relaxants are relaxation of striated muscles, mild weakness of skeletal muscles, decreased force of muscle contraction, and muscle stiffness. Other effects include generalized CNS depression manifested as sedation, somnolence, ataxia, and respiratory and cardiovascular depression. Indications Muscle relaxants are primarily used for the relief of painful musculoskeletal conditions such as muscle spasms, often following injuries such as low back strain. They are most effective when used in conjunction with physical therapy. They may also be used in the management of spasticity associated with severe chronic disorders such as multiple sclerosis and other types of cerebral lesions. Intravenous dantrolene is used for the management of skeletal muscle spasms that accompany the crisis condition known as malignant hyperthermia (see Chapter 11). Baclofen has been shown to be effective in relieving hiccups. 693 Contraindications The only usual contraindication to the use of muscle relaxants is known drug allergy, but contraindications for some drugs may include severe renal impairment. Adverse Effects The primary adverse effects of muscle relaxants are an extension of their effects on the CNS and skeletal muscles. Euphoria, lightheadedness, dizziness, drowsiness, fatigue, confusion, and muscle weakness are often experienced early in treatment. These adverse effects are generally short lived because patients grow tolerant to them over time. Less common adverse effects seen with muscle relaxants include diarrhea, GI upset, headache, slurred speech, muscle stiffness, constipation, sexual difficulties in males, hypotension, tachycardia, and weight gain. Toxicity and Management of Overdose The toxicities and consequences of an overdose of muscle relaxants primarily involve the CNS. There is no specific antidote (or reversal drug) for muscle relaxant overdoses. They are best treated with conservative supportive measures. More aggressive therapies are generally needed when muscle relaxants are taken along with other CNS depressant drugs in an overdose. An adequate airway must be maintained, and means of artificial respiration must be readily available. Electrocardiographic monitoring needs to be instituted, and large quantities of intravenous fluids are administered to avoid crystalluria. Interactions When muscle relaxants are administered along with other depressant drugs such as alcohol and benzodiazepines, caution needs to be used to avoid overdosage. Mental confusion, anxiety, tremors, and additive hypoglycemic activity have also been reported with this combination. A dosage reduction and/or discontinuance of one or both drugs is recommended. 694 Dosages For dosage information about commonly used muscle relaxants, see the table on this page. Dosages Selected Muscle Relaxants Drug (Pregnancy Pharmacologic Usual Adult Dosage Category) Class Range baclofen (Lioresal) Centrally PO: 5–20 mg 3 times daily (C) acting (max: 20 mg PO qid) cyclobenzaprine Centrally PO: 5–10 mg (Flexeril) (B) acting Indications/Uses Spasticity Spasticity Drug Profiles With the exception of dantrolene (Dantrium), which acts directly on skeletal muscle tissues, muscle relaxants are classified as centrally acting drugs because of their site of action in the CNS. These include baclofen (Lioresal), carisoprodol (Soma), chlorzoxazone (Paraflex), cyclobenzaprine (Flexeril), metaxalone (Skelaxin), methocarbamol (Robaxin), and tizanidine (Zanaflex). Carisoprodol has become a popular drug of abuse. When combined with an opioid and a benzodiazepine, it is known as “The Holy Trinity.” This combination produces a heroin-like effect. Use of all muscle relaxants is contraindicated in patients who have shown a hypersensitivity reaction to them or have compromised pulmonary function, active hepatic disease, or impaired myocardial function. Dosage information appears in the dosages table for muscle relaxants. baclofen Baclofen (Lioresal) is available in both oral and injectable dosage forms. The injectable form is for use with an implantable baclofen pump device. This method is sometimes used to treat chronic spastic muscular conditions. With this route, a test dose needs to be administered initially to test for a positive response. The injection is diluted before infusion. Both oral and injectable doses are titrated to 695 a desired response. Pharmacokinetics: Baclofen Route PO Onset of Action 0.5–1 hr Peak Plasma Concentration 2–3 hr Elimination Half- Duration of Life Action 2.5–4 hr 8 hr or longer cyclobenzaprine Cyclobenzaprine (Flexeril) is available in a 5- and 10-mg dose and an extended-release formulation (Amrix). Cyclobenzaprine is a centrally acting muscle relaxant that is structurally and pharmacologically related to the tricyclic antidepressants. It is the most commonly used drug in this class to reduce spasms following musculoskeletal injuries. It is very common for patients to exhibit marked sedation from its use. Pharmacokinetics: Cyclobenzaprine Route PO Onset of Action 1 hr Peak Plasma Concentration 3–8 hr Elimination Half- Duration of Life Action 8–37 hr 12–24 hr Nursing Process Assessment Before administering any CNS depressant drug, such as a benzodiazepine, nonbenzodiazepine, muscle relaxant, barbiturate, orexin receptor antagonists, or miscellaneous drug, perform an assessment focusing on some of the more common parameters and data, including the following: (1) complaints of any insomnia with attention to onset, duration, frequency, and pharmacologic, as well as nonpharmacologic, measures used; (2) any concerns voiced by the patient or family of sleep disorders, sleep patterns, difficulty in sleeping, or frequent awakenings; (3) the time it takes to fall asleep and the energy level upon awakening; (4) vital signs with attention to blood pressure (both supine and standing measurements); pulse rate and rhythm; respiratory rate, rhythm, and depth; body 696 temperature; and presence of pain; (5) thorough physical assessment/examination for baseline comparisons; (6) neurologic findings with a focus on any changes in mental status, memory, cognitive abilities, alertness, level of orientation (to person, place, and time) or level of sedation, mood changes, depression or other mental disorder, changes in sensations, anxiety, and panic attacks; and (7) miscellaneous information about medical history; allergies; use of alcohol; smoking history; caffeine intake (especially 6 hours prior to bedtime); past and current medication profile, with notation of use of any prescription drugs, over-the-counter drugs, and herbals; alternative or folk practices; and any changes in health status, weight, nutrition, exercise, life stressors (including loss and grief), or lifestyle. For patients taking benzodiazepines or benzodiazepine-like drugs, assessment needs to also focus on the identification of disorders or conditions that represent cautions or contraindications to use of these drugs, as well as drugs the patient is taking that might interact with benzodiazepines or benzodiazepine-like drugs (see pharmacology discussion for more information and for the FDA's black box warning). Closely monitor those who are anemic, suicidal, or have a history of abusing drugs, alcohol, or other substances. Other significant cautions pertain to use of these drugs in the very young or in older adults because of their increased sensitivity to these drugs. Cautions are also extended to the pregnant or lactating patient. The very young and older adult patient may require lower dosages due to potential ataxia and excessive sedation. In addition, before initiating drug therapy with the benzodiazepines and other sedative-hypnotic drugs, including barbiturates, the prescriber may order blood studies such as a CBC). Renal function studies (BUN] or creatinine levels) and/or hepatic function studies (ALP] level) may be ordered to rule out organ impairment and prevent potential toxicity or complications resulting from decreased excretion and/or metabolism. Potential drug interactions for benzodiazepines are presented in Table 12.4. Pay particular attention to the concurrent use of other CNS depressants (e.g., opioids) because this may lead to severe decreases in blood pressure, respiratory rate, reflexes, and level of consciousness. 697 With the nonbenzodiazepines such as zolpidem tartrate, include a head-to-toe physical assessment and a thorough medication history with measurement of vital signs and other parameters previously mentioned. Assess and document for allergies to these drugs and to aspirin. If the patient is allergic to aspirin, there is an associated risk for allergies to nonbenzodiazepines. Other considerations include the need for assessment of any confusion and lightheadedness, especially in older adults because of their increased sensitivity. Do not use eszopiclone in those younger than 18 years, and use extreme caution if there is a history of compromised respiratory status or drug, alcohol, or other substance abuse. Drug interactions include other CNS depressants. Gender of the patient is also important to consider in assessment because of the reduced dosage recommended by the FDA for female patients (see pharmacology discussion). For muscle relaxants, always note drug allergies before use, and perform a complete head-to-toe assessment with a focus on the neurologic system. In the older adult, there is increased risk for CNS toxicity with possible hallucinations, confusion, and excessive sedation. Assessment includes taking a thorough health/medication history and examining the complete patient profile with results of associated laboratory studies. See the pharmacology discussion about cautions, contraindications, and drug interactions. Barbiturates are discussed further in Chapter 14, along with other antiepileptic drugs. However, a brief description is needed to emphasize the importance of conducting a thorough patient assessment, as well as evaluating for cautions, contraindications, and drug interactions. Barbiturates are not to be used by pregnant or lactating women. These drugs cross the placenta and breastblood barriers, posing a risk for respiratory depression in the fetus and neonate. Withdrawal symptoms may appear in neonates born to women who have taken barbiturates during their last trimester of pregnancy. Barbiturates may also produce paradoxical excitement in children and confusion and mental depression in the older adult, so baseline neurologic assessment is needed. Assessment of renal and liver function is also important in those with compromised organ function and in the older adult to help avoid toxicity. The miscellaneous drug ramelteon is a newer medication that is 698 used for insomnia but is not associated with CNS depression, does not carry the potential for abuse or dependence, and does not lead to withdrawal symptoms when treatment stops. Therefore this drug can be used for patients who are likely to be abusers of CNS depressants. Include inquiry into sleep patterns and habits in your assessment. Because this drug is not to be used in patients with liver impairment, liver function studies are needed prior to beginning the medication. Perform respiratory assessment and assessment of other vital signs as well. If the patient has a history of respiratory disorders such as chronic obstructive pulmonary disease or sleep apnea, or if the patient is a child, this medication would not be indicated. Human Need Statements 1. Altered oxygenation, decreased, to respiratory depression associated with CNS depressants 2. Decreased self-determination related to inadequate information about the various CNS drugs and their firsttime use 3. Altered safety needs, risk for injury, related to the adverse effect of decreased sensorium 4. Altered safety needs, risk for injury, related to possible drug overdose or adverse reactions related to drug-drug interactions (e.g., combined use of the drug with alcohol, tranquilizers, and/or analgesics), decreased level of alertness, and an unsteady gait 5. Altered safety needs, risk for injury, related to physical or psychologic dependence on CNS drugs Planning: Outcome Identification 1. Patient maintains normal gas exchange and is free from respiratory depression through coughing, deep breathing, and taking medication as prescribed. 2. Patient demonstrates adequate knowledge about the drugs, including sedating/hypnotic properties, CNS depressant 699 effects and side effects of decreased respirations, altered cough, confusion, drowsiness, and drug interactions. 3. Patient remains free from self-injury and falls and demonstrates understanding of safety measures such as removing all throw rugs from walking areas (especially at night), changing positions slowly, ambulating with caution, and well-lit rooms at night. 4. Patient remains free from injury due to adequate information about drug interactions that lead to further CNS depression, such as other CNS depressants, herbals, opioids, alcohol, and other sedating over-the-counter products such as diphenhydramine. 5. Patient remains free from injury to self, with no drug dependence, and reports any problems with drug resistance, excessive sedation, or the need for more medication Implementation Patients taking benzodiazepines and other CNS depressants experience sedation and possible ataxia; thus there is a need for patient safety measures. Policies at hospitals or health care settings mandate the type of safety precautions to be taken, such as the use of side rails or bed alarms. Ambulation needs to occu
